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Study Name: Early Pseudomonas Infection Control (EPIC)
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Ramsey, Bonnie

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): TOBI
Number of Participants Being Recruited: 305
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study will examine how often antibiotics should be administered to produce the greatest reduction in respiratory infections and pulmonary exacerbations. The study will evaluate the effectiveness of two different approaches used to treat respiratory infections with antibiotics. One approach will focus on treating participants, based on findings of bacterial cultures taken throughout the study. The other approach will provide participants with antibiotics regularlyâ??every three months throughout the study. Antibiotics have proven effective in reducing respiratory infections caused by these bacteria. The antibiotic medications used in this study will be ciprofloxacinand inhaled tobramycin administered by a nebulizer. Both of these antibiotics have been proven effective at treating bacterial lung infections.
ELIGIBILITY
Age: 1 Years - 12 Years
FEV1: Not Applicable
P. aeruginosa status: Positive
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

To be eligible for this study, subjects must have early P. aeruginosa infection, defined as first isolation within 6 months prior to baseline or new isolation after at least a 2 year time frame with negative cultures.
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: Nelson, Amanda
(206) 884-7510
amanda.nelson2@seattlechildrens.org
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00097773?term=epic+clinical+and+cf&rank=1
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

This study compared cycled antibiotic therapy (administered quarterly regardless of culture findings) with culture-based therapy (administered only in response to Pseudomonas aeruginosa (Pa) positivity). Three hundred four CF subjects (age 1-12 years) with new onset Pa received either cycled therapy of 300mg TOBI® twice daily for 28 days with either 15-20 mg/kg twice daily ciprofloxacin or placebo for the first 14 days OR culture-based therapy of the same antibiotic therapies only during the quarters that their respiratory cultures were positive of Pa.
The primary clinical objective was to investigate if cycled antimicrobial treatment (with or without ciprofloxacin) reduced the time to first pulmonary exacerbation requiring intravenous antibiotics or hospital admission compared to culture-based therapy. There were no differences in the exacerbation rates between cycled and culture-based groups or between ciprofloxacin and placebo.

Secondary Efficacy:

No significant differences between groups were seen in the secondary endpoints of time to pulmonary exacerbation requiring any antibiotic usage or hospitalization, weight gain, and lung function.
No statistically significant differences were seen in the odds of a P. aeruginosaâ??positive culture comparing the cycled vs culture-based group or the ciprofloxacin vs. placebo group.

Safety:

Adverse events were similar across groups although respiratory events were more common in the groups assigned to receive oral ciprofloxacin.

Citation:

Arch Pediatr Adolesc Med 2011;165(9):847-856

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