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

Recruitment & Eligibility

Status: ot Recruiting

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Time-interval to next colonization with pseudomonas aeruginosa in the airways of CF-patients; differences between the two groups; one group treated with inhaled colomycin, oral ciprofloxacin and oral azithromycin and another group treated with inhaled colomycin, oral ciprofloxacin and placebo;Secondary Objective: 1) Clinical condition of the patients.<br>2) Microbiological characterization of pseudomonas aeruginosa (mucoid/non-mucoid, resistance-pattern).<br>3) Genotyping of pseudomonas aeruginosa, using Pulsed Field Gel Electrophoresis.<br>4) Specific, precipitating pseudomonas antibodies. (Crossed Immune Electrophoresis)<br>;Primary end point(s): Time to next appearance of pseudomonas in sputum samples.

Secondary Outcome Measures