- ClinicalTrials.gov ID: NCT05548283
- Recruiting participants (Starts Sep. 6, 2022)
- Not accepting healthy volunteers
- UTSW Principal Investigator: PREETI BHATIA SHARMA
summary
CFF treatment guidelines for the management of pulmonary exacerbations (PEx) identified evidence gaps in current clinical best practices. The STOP program offers a platform for the conduct of controlled trials to develop the evidence base in order to define clinical best practices. The study is a prospective, multicenter, parallel group study. Participants will be in a study for up to 48 days ((+ or -) 2 days): The interventional Aminoglycoside Study (AG Study) will be a randomized (1:1 ratio), open-label, superiority study of intravenous aminoglycoside and [BETA]-lactams versus intravenous [BETA]-lactams only. Randomization will occur at Visit 1
objective
The primary objective of this platform trial is to evaluate the efficacy and safety of differing treatments in CF PEx during a planned 14 day course of IV antimicrobials.