Status:
COMPLETED
Scandinavian Cystic Fibrosis Azithromycin Study
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
1+ years
Phase:
PHASE4
Brief 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 supplement...
Detailed Description
Cystic Fibrosis is the most common genetic, inherited, deadly disease in caucasians. The disease is characterized by recurrent airway-infections caused by Pseudomonas aeruginosa, ultimately leading to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00411736
Start Date
May 1 2008
End Date
March 1 2014
Last Update
March 14 2014
Active Locations (8)
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1
CF-centre Skejby, Skejby Sygehus, Brendstrupgaardsvej 100
Aarhus N, Denmark, 8200
2
CF-centre Copenhagen, Rigshospitalet, Blegdamsvej 9
Copenhagen, Denmark, 2100
3
CF-centre Bergen, Haukeland Universitetssykehus
Bergen, Norway, 5021
4
CF-centre Oslo, Ullevaal Universitetssykehus
Oslo, Norway, 0407