Status:
COMPLETED
Antimicrobial Resistance in Cystic Fibrosis (CF)
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Brief Summary
People with cystic fibrosis (CF) often develop chronic pulmonary infections which are caused by a variety of organisms, the most predominant being Pseudomonas aeruginosa. Antibiotics are important in ...
Detailed Description
Aminoglycosides are one of the mainstays of antibiotic therapy in CF. They are administered parenterally in synergistic combinations with β-lactam antibiotics for acute exacerbations and used by inhal...
Eligibility Criteria
Inclusion
- \> 6 years of age.
- Documented sweat chloride greater than 60 mEq/mL by quantitative pilocarpine iontophoresis test or homozygous for deltaF508 genetic mutation (or heterozygous for two well-characterized mutations) and one or more clinical features consistent with CF.
- Most recent FEV1 between 25% and 75% predicted when clinically stable; must be obtained at or within 3 months prior to study visit.
- P. aeruginosa present in the most recent sputum or throat culture obtained within 6 months prior to study visit.
- Able to expectorate sputum on a routine basis.
- Written informed consent provided.
Exclusion
- Administration of any anti-pseudomonal antibiotics by any route within 14 days prior to study visit.
- Participation in a research protocol that potentially involves antibiotic treatment within 14 days prior to study visit.
- Requiring treatment with intravenous or inhaled anti-pseudomonal antibiotics at study visit.
- B. cepacia complex present in the most recent sputum or throat culture obtained within 6 months prior to study visit.
- Post lung transplantation.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00360503
Start Date
March 1 2006
End Date
June 1 2008
Last Update
February 10 2009
Active Locations (1)
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1
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105