Antibiotic    (DrugBank: -)

1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症48

299. 嚢胞性線維症 [臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162
Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
48 / 1,592 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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PhaseCountries
1NCT04553419
(ClinicalTrials.gov)
July 27, 202011/9/2020Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CFAntibiotic Treatment Of Staphylococcus Aureus In Stable People With CF (ASAP-CF) Clinical Research ProtocolCystic FibrosisDrug: Cephalexin;Drug: PlaceboUniversity of British ColumbiaThe Hospital for Sick ChildrenRecruiting3 Years16 YearsAll86Phase 3Canada
2EUCTR2019-000955-16-AT
(EUCTR)
28/01/202007/01/2020Characterization of lung concentrations of the antibiotics piperacillin/tazobactam and levofloxacinPulmonary pharmacokinetics of piperacillin/tazobactam and levofloxacin in patients with chronic obstructive pulmonary disease or cystic fibrosis: Comparison of epithelial lining fluid, in-vivo microdialysis and tissue biopsy Pneumonia;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Trade Name: Piperacillin/Tazobactam Kabi - Fresenius Kabi Austria
INN or Proposed INN: piperacillin
Other descriptive name: PIPERACILLIN
INN or Proposed INN: tazobactam
Other descriptive name: TAZOBACTAM
Trade Name: Levofloxacin Kabi
INN or Proposed INN: levofloxacin
Other descriptive name: LEVOFLOXACIN HEMIHYDRATE
Medical University of ViennaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Phase 4Austria
3NCT03309358
(ClinicalTrials.gov)
September 28, 20175/10/2017A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic FibrosisA Multiple-Site, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety and Tolerability of Inhaled SNSP113 in Healthy Male Subjects (Part A) and Subjects With Stable Cystic Fibrosis (Part B)Lung Diseases;Pulmonary Disease;Cystic Fibrosis;Cystic Fibrosis Lung;Cystic Fibrosis Pulmonary Exacerbation;Cystic Fibrosis With Exacerbation;Respiratory Tract Disease;Pulmonary Inflammation;Multi-antibiotic Resistance;Antibiotic Resistant Infection;Lung Infection;Lung Infection Pseudomonal;Lung; Infection, Atypical Mycobacterium;Burkholderia Infections;Burkholderia Cepacia Infection;Lung InflammationDrug: Inhaled SNSP113;Drug: Inhaled PlaceboSynspira, Inc.NULLTerminated18 Years50 YearsAll32Phase 1United Kingdom
4NCT03066453
(ClinicalTrials.gov)
June 13, 201723/2/2017Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic FibrosisEvaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.Cystic FibrosisDrug: Tobi Inhalant Product;Drug: NebcinUniversity Hospital, LilleNULLRecruiting8 YearsN/AAll97Phase 3France
5NCT02888730
(ClinicalTrials.gov)
February 16, 201722/6/2016Tobramycin Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis PatientsEfficacy of Antibiotic (Tobramycin) Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients: A Multicenter Double-blind Randomized Controlled TrialCystic Fibrosis;Rhinosinusitis;Lung DiseasesDrug: Tobramycin nebulized nasally;Drug: Physiologic serum nebulized nasallyVirginie ESCABASSEHenri Mondor University HospitalRecruiting7 YearsN/AAll86Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-003399-58-DK
(EUCTR)
14/01/201707/01/2016Can antibiotic treatment improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma?Target-ABC (Targeted AntiBiotics for Chronic pulmonary disease):Can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma? - Target-ABC (Targetted AntiBiotics for Chronic pulmonary disease) Respiratory tract infection Bacterial infection with Pseudomonas aeruginosaChronic obstructive pulmonary disease (COPD)Non-cystic fibrosis bronchiectasisAsthma
MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin
INN or Proposed INN: ciprofloxacin hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Product Name: Piperacillin/Tazobactam
INN or Proposed INN: piperacillin sodium , tazobactam sodium
Other descriptive name: PIPERACILLIN SODIUM
COP:TRIN Region Hovedstaden (Gentofte hospital)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Denmark
7EUCTR2016-002832-34-GB
(EUCTR)
11/11/201603/10/2016The use of an inhaled antibiotic called Cayston to treat acute chest infections in people with CFAztreonam for inhalation for the treatment of acute exacerbations in cystic fibrosis. An open-label, randomised, cross-over pilot study of AZLI plus intravenous Colistin versus standard dual intravenous therapy. - AZTEC-CF Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Cayston
INN or Proposed INN: Aztreonam
Other descriptive name: Cayston
Liverpool Heart & Chest HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 4United Kingdom
8EUCTR2016-002578-11-GB
(EUCTR)
16/09/201609/08/2016A trial to determine the safest and most effective antibiotic strategy for infants diagnosed with CF.The cystic fibrosis (CF) anti-staphylococcal antibiotic prophylaxis trial (CF START); a randomised registry trial to assess the safety and efficacy of flucloxacillin as a longterm prophylaxis agent for infants with CF. - CF START Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Flucloxacillin 250mg/5ml Sugar-Free Powder for Oral Solution
Product Name: Flucloxacillin
Product Code: na
INN or Proposed INN: Flucloxacillin
Alder Hey Children's NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 4United Kingdom
9EUCTR2016-001785-29-IE
(EUCTR)
15/08/201610/05/2016Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF.Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Kalydeco
INN or Proposed INN: IVACAFTOR
Trade Name: Ciprofloxacin
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Product Name: Flucloxicillin
INN or Proposed INN: FLUCLOXACILLIN SODIUM
Trade Name: Fortum
INN or Proposed INN: CEFTAZIDIME
Product Name: Tobramycin
INN or Proposed INN: TOBRAMYCIN SULFATE
Trade Name: Meropenem
INN or Proposed INN: Meropenem
Other descriptive name: MEROPENEM
Trade Name: Colistin
INN or Proposed INN: COLISTIMETHATE SODIUM
St. Vincent's University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Ireland
10NCT02781610
(ClinicalTrials.gov)
June 201612/5/2016Standardized Treatment of Pulmonary Exacerbations IIStandardized Treatment of Pulmonary Exacerbations II (STOP2)Pulmonary Cystic FibrosisDrug: Standard of care IV antibiotic(s)Chris GossCystic Fibrosis Foundation;CF Therapeutics Development Network Coordinating Center;Medical University of South Carolina;University of WashingtonCompleted18 YearsN/AAll1048Phase 4United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-003881-96-IT
(EUCTR)
17/05/201605/11/2020Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic ¿brosisPseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing classic treatment protocols with classic treatment together with antibiotic treatment of upper airways. - Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML
Product Name: NA
Product Code: [NA]
INN or Proposed INN: COLISTIMETATO SODICO
Other descriptive name: COLISTIN
AZIENDA OSPEDALIERO-UNIVERSITARIA MEYERNULLNot RecruitingFemale: yes
Male: yes
112Phase 3Italy
12EUCTR2016-000398-19-BE
(EUCTR)
08/03/201609/02/2016Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients.Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients. - pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem Cystic fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Trade Name: Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie
INN or Proposed INN: Meropenem Fresenius Kabi
Other descriptive name: MEROPENEM TRIHYDRATE
Trade Name: Ceftazidim Fresenius Kabi 2000 mg poeder voor oplossing voor injectie of infusie
INN or Proposed INN: Ceftazidim Fresenius Kabi
Other descriptive name: CEFTAZIDIME PENTAHYDRATE
Trade Name: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
Other descriptive name: PIPERACILLIN SODIUM
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
Other descriptive name: TAZOBACTAM SODIUM
Trade Name: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
Other descriptive name: PIPERACILLIN SODIUM
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
Other descriptive name: TAZOBACTAM SODIUM
Ghent UniversityNULLNot RecruitingFemale: yes
Male: yes
45Phase 4Belgium
13NCT02840136
(ClinicalTrials.gov)
February 201618/7/2016LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis PatientsOptimisation, Valorisation and Application of UPLC-MS/MS Based Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients - Part 3: Non-blank Sputum Samples for Method Optimisation and ValidationCystic FibrosisDrug: Piperacillin-tazobactam combination product;Drug: Meropenem;Drug: CeftazidimeUniversity GhentKing Baudouin Foundation;Belgische Vereniging voor Strijd tegen MucoviscidoseSuspended12 YearsN/AAll40N/ABelgium
14NCT02489955
(ClinicalTrials.gov)
February 201518/5/2015Antibiotic Nephrotoxicity in Adult Patients With Cystic FibrosisProspective Randomised Trial of 'Area Under the Curve' (AUC) Dosing Strategy for Intravenous Tobramycin Versus Standard Trough Dosing for Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis (CF)Cystic FibrosisDrug: Amikacin;Drug: Tobramycin;Drug: ColomycinThe Leeds Teaching Hospitals NHS TrustNULLRecruiting18 YearsN/ABothN/AUnited Kingdom
15NCT02526004
(ClinicalTrials.gov)
January 201510/8/2015Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results StratifiedCystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results StratifiedCystic FibrosisDrug: Ceftazidime;Drug: TobramycinUniversity College CorkQueen's University, Belfast;Paris Descartes University;University of Dundee;University of Washington;University Hospital Heidelberg;Teagasc;Clininfo;GABO:mi;Papworth Hospital;Katholieke Universiteit Leuven;Assistance Publique - Hôpitaux de Paris;European UnionRecruiting16 Years80 YearsBoth252N/AIreland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02372383
(ClinicalTrials.gov)
October 201420/6/2014Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic FibrosisPharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus ControlsCystic FibrosisDrug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: PancrelipaseUniversity of Colorado, DenverCystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences InstituteCompleted16 Years45 YearsBoth32N/AUnited States
17EUCTR2014-001401-41-NL
(EUCTR)
29/07/201415/05/2014Once daily deep inhalation of tobramycin with smart nebulizer more effective to treat small airways disease in cystic fibrosis?Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis - TAPAS study in patients with CF Cystic Fibrosis and chronic infection with Pseudomonas aeruginosa;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Bramitob 300mg/4ml Nebuliser SolutionNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Netherlands
18NCT02113397
(ClinicalTrials.gov)
April 20149/4/2014Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis LungComparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled ColistimethateCystic FibrosisDrug: TOBI™ Podhaler™ 112 mg inhaled twice daily;Drug: Colistimethate 75 mg inhaled two times dailyDartmouth-Hitchcock Medical CenterNovartis PharmaceuticalsTerminated12 Years75 YearsAll1United States
19EUCTR2013-004488-30-NL
(EUCTR)
31/01/201411/12/2013Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK)Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) - TAPAS-PK study in patients with CF Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Bramitob
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: TOBRAMYCIN
Haga HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
20NCT01641822
(ClinicalTrials.gov)
December 201213/7/2012Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CFA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic FibrosisCystic FibrosisDrug: AZLI;Drug: Placebo to match AZLI;Drug: Tobramycin inhalation solutionGilead SciencesNULLCompleted6 YearsN/AAll107Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
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agemax
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gender
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size
PhaseCountries
21NCT01695343
(ClinicalTrials.gov)
December 201225/9/2012Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic TreatmentA Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas AeruginosaCystic FibrosisBiological: KB001-A;Drug: Placebo ComparatorKaloBios PharmaceuticalsNULLCompleted12 Years50 YearsBoth182Phase 2United States;Australia;Israel;New Zealand
22NCT01667094
(ClinicalTrials.gov)
September 201213/8/2012A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic FibrosisContinuous-infusion Anti-pseudomonal ß-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic FibrosisCystic FibrosisDrug: Intermittent, short infusion Ceftazidime;Drug: Continuous infusion Ceftazidime;Drug: Intermittent, short infusion Meropenem;Drug: Continuous infusion Meropenem;Drug: Intermittent, short infusion Ticarcillin-clavulanate;Drug: Continuous infusion Ticarcillin-clavulanate;Drug: Intermittent, short infusion Cefepime;Drug: Continuous infusion Cefepime;Drug: Continuous infusion Piperacillin tazobactam;Drug: Intermittent, short infusion Piperacillin tazobactamThe AlfredNULLActive, not recruiting18 YearsN/AAll50Phase 4Australia
23NCT02295566
(ClinicalTrials.gov)
May 201120/8/2014RATNO, Reducing Antibiotic Tolerance Using Nitric Oxide in CF - a Phase 2 Pilot StudyRATNO (Reducing Antibiotic Tolerance Using NO) Reducing Antibiotic Tolerance Using Low Dose Nitric Oxide in Cystic Fibrosis - a Phase 2 Pilot StudyCystic FibrosisDrug: Nitric Oxide;Drug: ControlUniversity Hospital Southampton NHS Foundation Trust.University of SouthamptonCompleted12 YearsN/ABoth12Phase 2United Kingdom
24NCT01313624
(ClinicalTrials.gov)
April 201110/3/2011Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial InfectionBronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll266Phase 3United States;Australia;Canada
25NCT01314716
(ClinicalTrials.gov)
April 201111/3/2011Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)BronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll274Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2010-023529-39-GB
(EUCTR)
18/02/201131/12/2010Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0 Cystic FibrosisTrade Name: INOmax 400ppm mol/mol inhalation gas
Product Name: Nitric Oxide
Product Code: NO
Southampton University Hopsitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
27NCT01090908
(ClinicalTrials.gov)
September 201011/3/2010Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. AeruginosaA Multi-Center, Open Label Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Ciprofloxacin For Inhalation (CFI) Given Daily For 14 Days To Stable Cystic Fibrosis Patients Ages 6 To 17 With Pseudomonas AeruginosaCystic FibrosisDrug: AntibioticAradigm CorporationNULLWithdrawn6 Years18 YearsBoth0N/ANULL
28EUCTR2007-004277-26-AT
(EUCTR)
21/01/201021/04/2009An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Cayston
Product Name: AZLI
Product Code: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
29NCT01044719
(ClinicalTrials.gov)
January 201014/12/2009Duration of Antibiotics in Infective Exacerbations of Cystic FibrosisWhat Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas AeruginosaCystic FibrosisDrug: Ceftazidime;Drug: Tobramycin;Drug: MeropenemImperial College LondonNULLNot yet recruiting16 YearsN/ABoth240Phase 4United Kingdom
30EUCTR2009-014042-28-GB
(EUCTR)
16/10/200914/10/2010What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosisWhat duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosis Cystic FibrosisTrade Name: Meropenem
Product Name: Meropenem
INN or Proposed INN: Meropenem
Trade Name: Ceftazidime
Product Name: Ceftazidime
INN or Proposed INN: Ceftazidime
Trade Name: Tobramycin
Product Name: Tobramycin
INN or Proposed INN: Tobramycin
Imperial College, LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2007-004277-26-GB
(EUCTR)
12/03/200908/02/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Cayston
Product Name: AZLI
Product Code: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
32EUCTR2007-004277-26-PT
(EUCTR)
12/12/200817/10/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
Product Code: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
33EUCTR2007-004277-26-DE
(EUCTR)
14/10/200829/05/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Cayston
Product Name: AZLI
Product Code: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
34EUCTR2007-004277-26-ES
(EUCTR)
25/08/200824/01/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quísticaAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA).
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
35NCT00757237
(ClinicalTrials.gov)
August 200822/9/2008Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas AeruginosaAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only)Cystic FibrosisDrug: Aztreonam for Inhalation Solution (AZLI);Drug: Tobramycin Inhalation Solution (TIS)Gilead SciencesChiltern International Inc.;ClinPhone, Inc.;CovanceCompleted6 YearsN/AAll274Phase 3United States;Austria;Belgium;Denmark;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2007-004277-26-IE
(EUCTR)
19/06/200827/02/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
37EUCTR2007-004277-26-NL
(EUCTR)
10/06/200829/05/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
38EUCTR2007-004277-26-FR
(EUCTR)
30/04/200821/01/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
39EUCTR2007-004277-26-BE
(EUCTR)
29/04/200820/12/2007An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
273Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
40EUCTR2007-004277-26-IT
(EUCTR)
23/04/200817/06/2008An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - NDAn open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: aztreonan lysine
Product Code: AZLI
INN or Proposed INN: Aztreonam
Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML
INN or Proposed INN: Tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2008-006502-42-IT
(EUCTR)
22/04/200807/04/2010Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007 Cystic fibrosis
MedDRA version: 9.1;Level: SOC;Classification code 10038738
Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML
INN or Proposed INN: Tobramycin
INN or Proposed INN: Colistin
INN or Proposed INN: Ciprofloxacin
AZIENDA OSPEDALIERA MEYERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
42EUCTR2007-004277-26-DK
(EUCTR)
16/04/200812/03/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
43NCT00104520
(ClinicalTrials.gov)
February 20051/3/2005Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. AeruginosaA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)Cystic FibrosisDrug: AZLI 75 mg two times a day (BID)/three times a day (TID);Drug: Placebo two times a day (BID)/three times a day (TID)Gilead SciencesNULLCompleted6 YearsN/AAll211Phase 3United States
44NCT00823238
(ClinicalTrials.gov)
July 200429/12/2008Comparison of Antibiotics for Pseudomonas in Early CFComparison of Antibiotics for Pseudomonas in Early CFCystic FibrosisDrug: ceftazidime and tobramycin;Drug: inhaled tobramycinUniversity of North Carolina, Chapel HillCystic Fibrosis Foundation TherapeuticsCompleted3 Months16 YearsBoth21Phase 1United States
45NCT00205634
(ClinicalTrials.gov)
December 200012/9/2005Macrolide Antibiotic Therapy for Patients With Cystic FibrosisMacrolide Antibiotic Therapy for Patients With Cystic FibrosisCystic FibrosisDrug: Biaxin ( clarithromycin)Wake Forest UniversityAbbottCompleted6 Years50 YearsAll50Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2007-004277-26-Outside-EU/EEA
(EUCTR)
02/02/2015A Clinical Trial to Evaluate the Efficacy and Safety of the drug Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) in comparison to the drug Tobramycin Nebulizer Solution (TNS) in patients with Cystic Fibrosis.An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension. Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Trade Name: TOBI
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: TOBRAMYCIN
Gilead Sciences IncNULLNAFemale: yes
Male: yes
268Phase 3United States
47EUCTR2015-000398-11-Outside-EU/EEA
(EUCTR)
03/02/2015A Clinical Trial to Assess the Safety and Efficacy of an Alternating Therapy of Antibiotics with the Drug Aztreonam for Inhalation Solution (AZLI) for the Treatment of Lung Infection by the bacteria Pseudomonas aeruginosa in Patients with Cystic Fibrosis.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa Infection in Subjects with Cystic Fibrosis Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Trade Name: TOBI®
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: TOBRAMYCIN
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
250Phase 3United States
48EUCTR2014-003882-10-FR
(EUCTR)
29/07/2015Evaluation of the efficacy of antibiotic treatments associated with the Nebcine® as intravenous injection only and / or monitoring of aerosols of Tobi® in order to optimize the therapeutic management of exacerbations in patients with cystic fibrosis .Evaluation of the effectiveness of a treatment involving one (or several ) antibiotic (s) with 14-day tobramycin ( Nebcine® ) by intravenous injection versus the same antibiotic treatment (s ) associated with only 5 days of tobramycin ( Nebcine® ) by intravenous injection followed tobramycin aerosol ( Tobi® ) for 9 days in the context of cystic fibrosis mucoviscidosis or cystic fibrosis
MedDRA version: 18.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: TOBI
Product Name: TOBI
Other descriptive name: TOBRAMYCIN
CHRU de LilleNULLNAFemale: yes
Male: yes
Phase 2France