COLISTIN ( DrugBank: Colistin )


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26

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT02894684
(ClinicalTrials.gov)
January 20171/9/2016Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic FibrosisAztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous TherapyCystic Fibrosis;Infection;PseudomonasDrug: Aztreonam;Drug: Standard CareLiverpool Heart and Chest Hospital NHS Foundation TrustUniversity of LiverpoolCompleted16 Years65 YearsMale16Phase 4United Kingdom
2EUCTR2016-002832-34-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
3EUCTR2016-001785-29-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
4NCT02918409
(ClinicalTrials.gov)
August 201612/4/2016IV Colistin for Pulmonary Exacerbations: Improving Safety and EfficacyIV Colistin for Pulmonary Exacerbations: Improving Safety and EfficacyCystic FibrosisDrug: Colistin;Drug: TobramycinNational Jewish HealthNULLActive, not recruiting18 YearsN/AAll51Phase 4United States
5EUCTR2015-003881-96-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
6EUCTR2015-003662-87-DK
(EUCTR)
13/11/201522/09/2015Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of lifePseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life - Pseudomonas, Tazocin or Colistin Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa.
MedDRA version: 18.1;Level: LLT;Classification code 10051190;Term: Pneumonia Pseudomonas aeruginosa;System Organ Class: 100000004862
MedDRA version: 18.1;Classification code 10050700;Term: Chronic respiratory disease NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: colistimethate sodium (promixin)
INN or Proposed INN: COLISTIMETHATE SODIUM
Trade Name: Piperacillin with Tazobactam (tazocin)
INN or Proposed INN: PIPERACILLIN
Other descriptive name: PIPERACILLIN
INN or Proposed INN: TAZOBACTAM
Other descriptive name: TAZOBACTAM
Aarhus University Hospital, Department of Respiratory MedicineNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
7EUCTR2012-001565-33-IE
(EUCTR)
08/01/201511/09/2014An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland
8EUCTR2013-004987-80-BE
(EUCTR)
28/08/201418/02/2014Colistin dosage through blood samples and sputum in Cystic Fibrosis (CF) populationColistin use in Cystic Fibrosis patients: pharmacokinetic studies (intravenous administration) in relation with pharmacodynamics, tolerance profile and risk of selection of resistance. Colistin use in Cystic Fibrosis patients
MedDRA version: 16.1;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: COLISTINEB 2MUI
INN or Proposed INN: Colistineb
Other descriptive name: COLISTIMETHATE SODIUM (A COMPONENT)
CUB - Hôpital ErasmeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
9EUCTR2013-004295-35-AT
(EUCTR)
30/04/201402/04/2014Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept studyLung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT Chronic lung P. Aeruginosa Infection
MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
INN or Proposed INN: aztreonam
Other descriptive name: AZTREONAM LYSINE
Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
INN or Proposed INN: COLISTIMETHATE SODIUM
Trade Name: TOBI
Product Name: Tobi
INN or Proposed INN: TOBRAMYCIN SULFATE
Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)NULLNot RecruitingFemale: yes
Male: yes
15Phase 4Austria
10NCT03341741
(ClinicalTrials.gov)
March 11, 20143/11/2017Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF PatientsCombined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF PatientsCystic Fibrosis With Pulmonary ManifestationsDrug: Tobramycin Powder;Drug: ColistinUniversity Hospital TuebingenNULLCompleted12 YearsN/AAll26Phase 3NULL
11NCT02288429
(ClinicalTrials.gov)
September 201315/9/2014Evaluation of Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate SodiumEvaluation of Steady-state Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate Sodium in Cystic Fibrosis and Critically Ill PatientsColistinDrug: colistimethate sodiumUniversity of Colorado, DenverNULLCompleted18 Years89 YearsAll16United States
12EUCTR2012-001565-33-ES
(EUCTR)
04/07/201316/05/2013An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Trade Name: TOBI 300 mg/5 ml solución para inhalación por nebulizador
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Trade Name: Promixin,1 millón de Unidades Internacionales,polvo para solución para inhalación por nebulizador
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Farmaceutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland
13EUCTR2012-001565-33-GB
(EUCTR)
21/06/201316/04/2013An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
67 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain;Ireland;Germany;Switzerland;United Kingdom
14EUCTR2012-001565-33-DE
(EUCTR)
05/06/201318/04/2013An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland
15EUCTR2011-006171-19-IT
(EUCTR)
27/10/201113/01/2012Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old.randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old. Cystic fibrosis patients with early P.aeruginosa infection.
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: CIPROXIN*6CPR RIV 500MG
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Trade Name: BRAMITOB*NEBUL 56F 300MG/4ML
INN or Proposed INN: TOBRAMYCIN
Trade Name: CIPROXIN*6CPR RIV 500MG
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Trade Name: PROMIXIN*NEBUL 30MONOD 1MUI
INN or Proposed INN: COLISTIN MESILATE SODIUM
AZIENDA OSPEDALIERA MEYERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
16EUCTR2011-000192-13-PL
(EUCTR)
08/07/201131/05/2011A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosisA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
28Poland;Ukraine;Germany;United Kingdom
17EUCTR2011-000192-13-DE
(EUCTR)
05/05/201105/04/2011A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosisA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
40Poland;Ukraine;Germany;United Kingdom
18EUCTR2011-000192-13-GB
(EUCTR)
28/04/201117/03/2011A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) studyA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
28Germany;United Kingdom;Poland
19NCT01035853
(ClinicalTrials.gov)
December 200917/12/2009Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa ColonizationSino-nasal Inhalation of Colistin Via the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Colonization of the Upper Airways With Pseudomonas AeruginosaCystic Fibrosis;Pseudomonas AeruginosaDrug: ColistinUniversity of JenaNULLCompleted6 YearsN/ABoth10Phase 2Germany
20EUCTR2008-007877-19-DE
(EUCTR)
15/06/200928/05/2009Nasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilotNasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Colistin CF
Product Name: Colistin CF
INN or Proposed INN: Colistimethat-Natrium
University of JenaNULLNot RecruitingFemale: yes
Male: yes
14Germany
21EUCTR2006-003275-12-NO
(EUCTR)
03/06/200927/03/2009Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Zitromax
Product Name: Zitromax
Product Code: Zitromax
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNAFemale: yes
Male: yes
250Phase 4Denmark;Norway;Sweden
22NCT00411736
(ClinicalTrials.gov)
May 200814/12/2006Scandinavian Cystic Fibrosis Azithromycin StudySupplementary Oral Azithromycin in Treatment of Intermittent Pseudomonas Aeruginosa Colonization in CF-patients With Inhaled Colistin and Oral Ciprofloxacin; Postponing Next Isolate of Pseudomonas and Prevention of Chronic Infection. A Prospective, Double-blinded, Placebo-controlled Scandinavian Multi-centre Study.Cystic FibrosisDrug: Study medication, azithromycin or placebo;Drug: Azithromycin or placebo tabletsRigshospitalet, DenmarkCystic Fibrosis Foundation TherapeuticsCompleted1 YearN/ABoth45Phase 4Denmark;Norway;Sweden
23EUCTR2008-006502-42-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
24EUCTR2006-003275-12-DK
(EUCTR)
23/05/200717/04/2007Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNot RecruitingFemale: yes
Male: yes
250Phase 4Denmark
25NCT01400750
(ClinicalTrials.gov)
August 200118/7/2011Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic FibrosisProspective Randomized Trial Comparing Oral Ciproxin Plus Inhaled Colistin With Tobramycin for Inhalation for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis.Cystic FibrosisDrug: oral ciprofloxacin plus inhaled colistin;Drug: TOBIUniversitaire Ziekenhuizen LeuvenNULLCompletedN/A18 YearsBoth61Phase 4Belgium
26EUCTR2006-003275-12-SE
(EUCTR)
07/07/2009Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: Azithromycin
Product Name: azithromycin
Product Code: azithromycin
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNAFemale: yes
Male: yes
250Phase 4Denmark;Norway;Sweden