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Study Name: OPTIMIZE
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Ramsey, Bonnie
Study Phase: 3
Recruitment Status: Not Yet Recruiting
Study Drug(s): Azithromycin
Number of Participants Being Recruited: 274
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this trial is to compare the effects of treatment with tobramcyin solution for inhalation (TIS) with and without azithromycin in people with CF age 6 months to 18 years who have their first isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 weeks. The trial will last up to 20 weeks.
ELIGIBILITY
Age: 6 Months - 18 Years
FEV1: Not Applicable
P. aeruginosa status: Positive
B. cepacia status: Negative
Other Primary Eligibility Requirements:

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:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT02054156
Clinical Research Terms Glossary: Click here
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