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RCT Meropenem vs Piperacillin-Tazobactam for Definitive Treatment of BSI's Due to Ceftriaxone Non-susceptible Escherichia Coli and Klebsiella Spp.

NCT02176122 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2017-11-27

No results posted yet for this study

Summary

No randomized controlled trials (RCTs) have yet been performed comparing different treatment options for AmpC or ESBL-producing Enterobacteriaceae. During the last 10 years we have seen an exponentially increasing rate of carbapenem resistance worldwide, including Australia and New Zealand. The investigators urgently need data from well-designed RCTs to guide clinicians in the treatment of antibiotic resistant Gram-negative infections. The investigators face a situation where a commonly used antibiotic for these infections (meropenem) may be driving carbapenem resistance. For this reason, the investigators are seeking to compare a carbapenem-sparing regimen with a carbapenem for the treatment of these infections. Formal evaluation of safety and efficacy of generic antibiotics in the treatment of infection is of immense clinical and public health importance, and no formal trial has yet been conducted to address these issues. The international collaboration between teams of clinician researchers, some of whom are leaders in their field, makes it highly likely that the outcomes of this trial will have a significant impact on clinical practice.

The investigators' hypothesis is that piperacillin/tazobactam (a carbapenem-sparing regimen) is non-inferior to meropenem (a widely used carbapenem) for the definitive treatment of bloodstream infections due to third-generation cephalosporin non-susceptible E. coli or Klebsiella species.

Conditions

Interventions

DRUG

Meropenem

Meropenem is a carbapenem anti-bacterial used for the treatment of serious infections in patients.

DRUG

Piperacillin-tazobactam combination product

Piperacillin-tazobactam is used for the treatment of patients with systemic and/or local bacterial infections.

Sponsors & Collaborators

  • International Society of Chemotherapy

    collaborator UNKNOWN

  • Australian Society for Antimicrobials

    collaborator UNKNOWN

  • Queensland Clinical Trials & Biostatistics Centre

    collaborator UNKNOWN

  • Australasian Society for Infectious Diseases

    collaborator OTHER

  • The University of Queensland

    lead OTHER

Principal Investigators

  • David L Paterson, MD, PhD · UQCCR, RBWH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-07-07
Completion
2017-08-07

Countries

  • Australia
  • Canada
  • Italy
  • Lebanon
  • New Zealand
  • Saudi Arabia
  • Singapore
  • South Africa
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02176122 on ClinicalTrials.gov