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Phase III, Randomized, Double-Blind, Study Evaluating Efficacy/Safety/Tolerability of Meropenem-Vaborbactam Compared to Piperacillin/Tazobactam in Adult Patients With Complicated Urinary Tract Infections, Including Acute Pyelonephritis

ClinicalTrials.gov · COMPLETED, 2016

550 participants

Abstract

Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).

Conditions: Urinary Tract Infection Complicated, Acute Pyelonephritis.

Primary outcome: Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit; Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure Visit; Proportion Of Participants In The Microbiological Evaluable (ME) Population Who Achieved A Microbiologic Outcome Of Eradication At The TOC Visit.

Enrollment: 550 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 550 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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