TREATMENT OF NEW ONSET PSEUDOMONAS AERUGINOSA IN YOUNG PTS WITH CYSTIC FIBROSIS

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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. Approximately 300 young children with CF ranging in age from 1 to 12 years will be enrolled at approximately 60 clinical centers nationwide to participate in an 18-month clinical trial. Children will be eligible to participate when Pa (Pseudomonas aeruginosa) is isolated for the first time from respiratory cultures or if Pa is recovered after at least a two-year history of negative respiratory cultures ( 1 culture/year). The 18-month clinical trial will investigate children assigned to two different antimicrobial treatment regimens: (1) culture-based therapy, and (2) cycled antibiotic therapy, i.e. treatment provided in quarterly cycles regardless of microbiology results. The study will further randomize subjects into treatment with Tobramycin solution for inhalation (TSI) and oral ciprofloxacin (Cipro¿) or TSI and oral placebo. The results from this trial will provide valuable information regarding the microbiologic and clinical efficacy, as well as safety, of these two early intervention treatment strategies.