Supplementary 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.

NCT00411736 Phase 4 COMPLETED

In patients with Cystic Fibrosis, recurrent airway infection caused by Pseudomonas aeruginosa ultimately leads to chronic airway infection. The purpose of this study is to determine whether supplementary low-dose azithromycin to standard inhaled colistin and oral ciprofloxacin in the treatment of intermittent pseudomonas airway-infection can postpone the next episode of intermittent pseudomonas airway-infection and prevent development of chronic airway-infection.

Details

Lead sponsor	Rigshospitalet, Denmark
Phase	Phase 4
Status	COMPLETED
Enrolment	45
Start date	2008-05
Completion	2014-03

Conditions

• Cystic Fibrosis

Interventions

• Study medication, azithromycin or placebo
• Azithromycin or placebo tablets

Primary outcomes

• Time to next airway-colonization (re-colonization) with Pseudomonas aeruginosa — up to 5 years

Countries

Denmark, Norway, Sweden