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Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP

NCT02166476 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2018-06-11

Study results available
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Summary

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

Interventions

DRUG

Meropenem-Vaborbactam

Meropenem-vaborbactam

DRUG

Piperacillin-Tazobactam

Piperacillin-tazobactam

DRUG

Levofloxacin

Levofloxacin

DRUG

Saline

Saline

Sponsors & Collaborators

Principal Investigators

  • Karen Fusaro · Sponsor GmbH

  • Keith Kaye · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-20
Primary Completion
2016-04-28
Completion
2016-04-28
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Brazil
  • Bulgaria
  • Czechia
  • Greece
  • Hungary
  • Italy
  • Peru
  • Poland
  • Romania
  • Slovakia
  • Slovenia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02166476 on ClinicalTrials.gov