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A Study of Meropenem-Vaborbactam Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

NCT03006679 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-01-11

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy, safety, tolerability, and pharmacokinetics (PK) of meropenem-vaborbactam compared to piperacillin/tazobactam for 7 to 14 days in the treatment of hospitalized adults who meet clinical, radiographic, and microbiological criteria for hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).

Conditions

  • Hospital-Acquired Bacterial Pneumonia
  • Ventilator-Associated Bacterial Pneumonia
  • Hospital-Acquired Pneumonia
  • Ventilator-Associated Pneumonia

Interventions

DRUG

Meropenem-Vaborbactam

meropenem 2 g and vaborbactam 2 g

DRUG

Piperacillin/Tazobactam

piperacillin 4 g and tazobactam 0.5 g

Sponsors & Collaborators

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2020-06-30
Completion
2020-12-31
FDA Drug
Yes

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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 NCT03006679 on ClinicalTrials.gov