EPIC - 001, CLINICAL TRIAL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multicenter randomized clinical trial assessing the clinical and microbiologic efficacy and safety of treatment with antimicrobial therapy at the time of new onset of Pa positive oropharyngeal, sputum or lower respiratory tract culture in young children with cystic fibrosis. Approximately three hundred participants will be randomized to one of two early anti-pseudomonal treatment algorithms (CYCLED or CULTURE-BASED THERAPY). All participants will receive an initial course of anti-pseudomonal antibiotic therapy consisting of 28 days of tobramycin solution for inhalation and a 14-day course of oral ciprofloxacin/placebo regardless of randomization assignment. If respiratory cultures sampled after three weeks of the first anti-pseudomonal cycle remains positive, participants will receive an additional 28-day course of TSI. During the remainder of the study, participants will be treated based on their randomization assignment as follows: CYCLED Therapy (n=150): a. Group I (n=75): TSI and oral placebo for six consecutive quarterly cycles b. Group II (n=75): combination therapy of TSI and oral ciprofloxacin for six consecutive quarterly cycles. CULTURE-BASED Therapy (n=150): a. Group I (n=75): TSI and oral placebo administered only when quarterly respiratory cultures are found positive for Pa. b. Group II (n=75): combination therapy of TSI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pa. Primary objectives include 1) Comparison of CYCLED Therapy to CULTURED-BASED Therapy on time to first pulmonary exacerbation requiring intravenous antibiotics and/or hospitalization during an 18-month study period and 2) compare the two treatment groups on the proportion of Pa positive isolates from respiratory cultures during an 18-month study period.