Scandinavian Cystic Fibrosis Azithromycin Study

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Diagnosis of Cystic Fibrosis based on genotype and/or positive sweat-test

• Written informed consent based on written and spoken information

• No chronic airway-infections with Gram-negative bacteria

• Fertile, sexually active women must use contraception (p-pills, IUD or other methods with a similar Pearl-index) when participating in the study

Exclusion Criteria:

• P. aeruginosa in airway secretions obtained less than 3 months prior to inclusion

• Chronic infection of the airways caused by Gram-negative bacteria (Burkholderia species, Achromobacter xylosoxidans, Pandorea apista or Stenotrophomonas maltophilia)

• Chronic infection of the airways caused by P. aeruginosa (chronic infection is defined by continuing growth of the microorganism for 6 months and/or an increase in specific, precipitating antibodies to a level of at least 2)

• Previous infection with a strain of P. aeruginosa resistant to ciprofloxacin or colistin

• Previous participation in a pseudomonas-vaccination-study

• Patients younger than 1 year

• Pregnant or lactating women, or sexually active women unwilling to use safe contraception (p-pills, IUD or method with similar Pearl-index) when participating in the study

• Severe insufficiency of the liver or kidneys as judged by the local investigator