Clinical Trial: A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 3, Randomized, Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Plazomicin Compared With Meropenem Followed by Optional Oral Therapy for the Treatment of Complicated Urin
Brief Summary: This is a randomized, multicenter, multinational, double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in the treatment of cUTI, including AP, in adults.
Detailed Summary:
Sponsor: Achaogen, Inc.
Current Primary Outcome:
- Composite outcome requiring both microbiological eradication and clinical cure rate in the microbiological modified intent-to-treat population [ Time Frame: Day 5 after study drug start ]
- Composite outcome requiring both microbiological eradication and clinical cure rate in the microbiological modified intent-to-treat population [ Time Frame: Day 17 (+/- 2 days) after study drug start ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Composite outcome requiring both microbiological eradication and clinical cure rate in the microbiologically evaluable population [ Time Frame: Day 5 after study drug start ]
- Composite outcome requiring both microbiological eradication and clinical cure rate in the microbiologically evaluable population [ Time Frame: Day 17 (+/- 2 days) after study drug start ]
- Overall incidence of adverse events [ Time Frame: 34 Days ]
Original Secondary Outcome: Same as current
Information By: Achaogen, Inc.
Dates:
Date Received: June 25, 2015
Date Started: January 2016
Date Completion:
Last Updated: October 4, 2016
Last Verified: October 2016
