STANDARD VERSUS BIOFILM SUSCEPTIBILITY TESTING IN 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. This is a randomized multi-center clinical trial that will compare the microbiological efficacy, clinical effecacy, and safety of using standard versus biofilm susceptibility testing of P. aeruginosa sputum isolates to guide selection form treatment of airway infection in clinically stable patients with CF. Patients will be screened to determine eligibility and to obtain a sputum culture. Eligible patients will be randomized to either the standard or biofilm study arm. Antibiotic selection will be performed centrally according to a standard algorithm using the susceptibility test results of the assigned study arm. On Day 0, patients will be started on a 14-day course of two antibiotics as selected per protocol. Antibiotics will be administered intravenoudly (IV) and / or orally. A follow-up phone call or visit will occur on Day 7. An end of treatment visit will be conducted after completion of antibiotic therapy.