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Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults

NCT02168946 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2019-03-04

Study results available
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Summary

Vabomere™, (meropenem-vaborbactam) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae

Conditions

  • Urinary Tract Infection Complicated
  • Acute Pyelonephritis
  • Hospital Acquired Bacterial Pneumonia
  • Ventilator-associated Bacterial Pneumonia
  • Bacteremia
  • Abdominal Infection

Interventions

DRUG

Vabomere

Vabomere for IV injection, administered as a 2 g/2 g dose

DRUG

Best Available Therapy

Antibiotic(s) chosen by Investigator

Sponsors & Collaborators

Principal Investigators

  • Karen Fusaro · Sponsor GmbH

  • Keith Kaye · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-07-21
Completion
2017-07-21
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Colombia
  • Greece
  • Israel
  • Italy
  • United Kingdom

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 NCT02168946 on ClinicalTrials.gov