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

Phase 1

• Conditions: Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.; MedDRA version: 8.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung

• Registration Number: EUCTR2006-003275-12-NO
• Lead Sponsor: Copenhagen CF-centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 250

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.
9) Age below 8 years with CF-siblings
10) Known allergy to any of the drugs used in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified