Antimicrobial Resistance in Cystic Fibrosis (CF)

Completed

Conditions studied: Cystic Fibrosis

In brief

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 managing CF lung infections. Antibiotic use in CF was altered about ten years ago with the approval of inhaled tobramycin, an aminoglycoside which is effective in treating P. aeruginosa. A decade later, CF clinicians are increasingly concerned about the likelihood of induction of aminoglycoside-resistance with prolonged use of inhaled tobramycin to treat chronic P. aeruginosa airway infections. The goal of this study is to examine the current microbiology and susceptibility of organisms from CF sputum, correlate it with antibiotic use, and compare it with previous data.

Key facts

Study ID

NCT00360503

Run by

Seattle Children's Hospital

People needed

304

Starts

2006-03-01

Expected to finish

2008-06-01

Last updated by the study team

2009-02-10

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital and Regional Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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