Trial Outcomes & Findings for Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis (NCT NCT01694069)

The study was terminated and the original PI has left the institution. Minimal results information is available; all efforts were made to retrieve more results information, but were unsuccessful. The available data does not indicate in which arm the participants were enrolled, therefore all available study data with be entered under All Study Participants.

Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis

FEV1 will be measured upon enrollment (day 0). FEV1 will also be measured at end of therapy (day 14). If FEV1 is available when patient was stable, prior to enrollment, this value will be treated as baseline FEV1. Change in FEV1 will be calculated from baseline (if available) to day 14 and also Day 0 to day 14

Serum piperacillin concentration will be measured as follows: * Intermittent infusion arm: prior to dose (trough), 30 minutes (after completion of infusion), and at 4 hours * Continuous infusion arm: collected at the same time as in the intermittent infusion arm

Patients will be followed for time of next subsequent pulmonary exacerbation for up to 52 weeks after completion of receiving study drug. Next pulmonary exacerbation is defined as requiring admission to a hospital for receipt of I.V. antibiotics because of a diagnosis of pulmonary exacerbation.

The validated CFQ-R will be administered to patients at time of enrollment at end of therapy

Sputum density of Pseudomonas aeruginosa will be determined at enrollment, day 3, and at end of therapy

The change in weight will be documented from enrollment to end of therapy

Temperature will be taken multiple times daily according to standard of care. If patients present febrile, time until patient is afebrile and remains afebrile for 24 hours will be recorded.

White blood cell (WBC) count will be measured once daily. If patient presents with WBC count greater than 11.0 x 10\^3/mL, time until patient has WBC less than 11.0 x 10\^3/mL will be recorded.

Failure of treatment will be defined as patient needing I.V. antibiotics beyond the 14 days allowed in this study. The primary medical team (along with a blinded investigator) treating the patient will determine whether patient requires additional therapy.