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Study Name: Antimicrobial Resistance in CF
Study Type: Observational
Intervention Category: Not Applicable
Study Sponsor: Burns, Jane

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: Other
Recruitment Status: Trial Completed
Study Drug(s): Not Applicable
Number of Participants Being Recruited: 520
Single / Multi-Center: Multi-Center
This study examined the antibiotic resistance of some organisms that cause respiratory infection in people with CF. People with CF often develop chronic pulmonary infections which are caused by a variety of organisms, the major one being the bacteria Pseudomonas aeruginosa. Chronic lung infections are associated with a decline in lung function in CF patients.

Antibiotic treatment of CF markedly changed nearly ten years ago with the introduction of inhaled tobramycin, an antibiotic used to treat P. aeruginosa infections. There is a concern that bacteria will become antibiotic resistant due to the prolonged use of tobramycin in treating chronic airway infections.

This study enrolled people with CF and compared their sputum microbiology and susceptibility data with data obtained years ago from tobramycin clinical trials. The comparisons between current and previous infections help scientists to determine if use of certain antibiotics has contributed to antibiotic resistance.
Age: >= 6 Years
FEV1: 25 - 75 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Negative
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on If a specific trial listing for this trial is available, a link to the specific listing will be present in the "More Information" section below.
Sponsor Contact Information: McNamara, Sharon
(206) 987-3921 X1
Trial Specific Link on
Clinical Research Terms Glossary: Click here
Primary Efficacy:

The study objective was to identify changes in cystic fibrosis (CF) sputum microbiology over 13 years. Sputum samples from 267 subjects from 33 US CF centers were collected and submitted for testing between June 2006 and August 2008. A total of 656 Pseudomonas aeruginosa isolates were identified from 253 culture-positive subjects. Comparison between the contempory group of subjects and the historic data from the inhaled tobramycin trials revealed an increase in the prevalence of subjects with tobramycin resistant (11.8% vs. 30.4%, P<0.001) and amikacin resistant (24.2% vs. 42.7%, P<0.001) P. aeruginosa. Prevalence of ciprofloxacin resistance was similar (34.4% vs. 33.6%, P¼0.81). The contempory groupof subjects were significantly older on average than those in the historical cohort (27.1 years vs. 20.7 years, P<0.0001). There was also a trend toward better lung function in the contemporary group; mean FEV1% predicted values at baseline in the historic group were 49.9 (tobramycin group) and 51.2 (placebo group), whereas mean FEV1% predicted was 53.9 for the contemporary group.

Secondary Efficacy:



Pediatr Pulmonol 2010;45:363-370

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