EUCTR2006-003275-12-SEActive, not recruitingPhase 1
Scandinavian 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
Copenhagen CF-centre0 sites250 target enrollmentStarted: July 7, 2009Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 250
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) Diagnosis of Cystic Fibrosis based on genotype and/or positive sweat-test.
- •2) Written informed consent from the patient or guardian, based on oral and written information about the trial.
- •3) Intermittent colonization of the airways with pseudomonas aeruginosa.
- •4) Fertile women must use safe contraception (p-pills, IUD or other methods with similar pearl-index) during the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1) Colonization of the airways with pseudomonas aeruginosa during the last 3 months prior to inclusion.
- •2) Chronic infection of the airways, caused by Gram-negative microorganisms; burkholderia complex, pandorea apista, stenotrophomonas maltophilia or achromobacter xylosoxidans.
- •3) Chronic infection of the airways caused by pseudomonas aeruginosa. (6 consecutive sputum samples with growth of the microorganism, and/or level of specific, precipitating antibodies of at least 2 against the microorganism.)
- •4) Previous infection with pseudomonas-strains resistant to colistin or ciprofloxacin.
- •5) Previous participation in pseudomonas-vaccination trials.
- •6) Patients under the age of 1 year.
- •7) Pregnant or breastfeeding women, or fertile women unwilling to use safe contraception (p-pills, IUD or other methods with similar pearl-index) during the study.
- •8) Severe liver- or kidney insufficiency as judged by the local investigator.
Investigators
Similar Trials
Active, not recruiting
Phase 1
Scandinavian 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 StudyEUCTR2006-003275-12-NOCopenhagen CF-centre250
Active, not recruiting
Phase 1
Scandinavian 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 StudyCystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.MedDRA version: 8.1Level: LLTClassification code 10011763Term: Cystic fibrosis lungEUCTR2006-003275-12-DKCopenhagen CF-centre250
Active, not recruiting
Not Applicable
Azole Therapy in Cystic Fibrosis (ATCF)Cystic fibrosisMedDRA version: 14.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 14.1Level: HLTClassification code 10003486Term: Aspergillus infectionsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-005799-41-GBCHU de Rennes (Rennes University Hospital Centre)150
Withdrawn
Phase 2
Study to Assess Efficacy of AZD1236 in Patients With Cystic FibrosisCystic FibrosisNCT00812045AstraZeneca44
Completed
Not Applicable
Observation of the treatment of cystic fibrosis patients with Pseudomonas aeruginosa lung infection with ColiFin 1Mio I.E. or ColiFin 2Mio I.E.Chronic infection with Pseudomonas aeruginosaCystic fibrosisE84B96.5Pseudomonas (aeruginosa) as the cause of diseases classified to other chaptersCystic fibrosisDRKS00009540PARI Pharma GmbH32