This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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 first Pa positive oropharyngeal, sputum or lower respiratory tract culture in young children with CF. Approximately three hundred participants will be equally randomized to one of two early anti-pseudomonal treatment algorithms (CYCLED or CULTURE-BASED THERAPY groups). All participants will receive open-label tobramycin solution for inhalation (TSI). Half of the participants in each treatment group will receive oral ciprofloxacin and the other half will receive oral placebo. At the beginning of the study, the initial treatment will be the same in both groups, regardless of randomization assignment: all participants will receive an initial course of antipseudomonal antibiotic therapy consisting of 28 days of tobramycin solution for inhalation and a 14-day course of oral ciprofloxacin/placebo. If respiratory cultures sampled after three weeks of the first antipseudomonal cycle remain Pa positive participants will receive an additional 28-day course of TSI. During the remainder of the study, participants will be randomized to the following groups: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.Participants presenting in a stable condition at Baseline will be assigned to one of the study regimens. Study participants presenting at Baseline with new onset of a pulmonary exacerbation requiring intravenous antibiotics or hospital admission will be considered screening failures, but may be re-enrolled at the following quarter if they meet the study eligibility criteria.
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