Ertapenem Versus Meropenem/Imipenem for ESBL+ Gram-negative Infections

December 29, 2011 updated by: Visanu Thamlikitkul, Mahidol University

An Open-label, Randomized Equivalence Trial and Cost-effectiveness Analysis of Ertapenem Versus Other Carbapenems for Treatment of Extended -Spectrum Beta-Lactamase (ESBL)-Producing Gram-negative Bacterial Infections

Adult patients with ESBL-producing Gram negative infections are randomized to receive ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups are compared.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Ertapenem is active against ESBL-producing Gram negative bacteria. This study is conducted to determine if ertapenem is effective against ESBL-producing Gram negative infections similar to meropenem/imipenem.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
        • Principal Investigator:
          • Visanu Thamlikitkul, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized patients aged >18 years with documented ESBL +ve GNB infection
  • Receive meropenem or imipenem/cilastatin as empiric antibiotic therapy

Exclusion Criteria:

  • Having been treated with meropenem or imipenem/cilastatin for longer than 72 hours
  • Have active P. aeruginosa co-infection
  • Pregnancy or breast feeding
  • Allergy to carbapenems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ertapenem
Ertapenem 1 gram per day for 7 to 14 days
Drug: Ertapenem
Ertapenem 1 gram per day for 7 to 14 days
Other Names:
  • Invanz
Active Comparator: Meropenem or Imipenem
Meropenem or Imipenem o.5 or 1 gram 3 to 4 times a day for 7 to 14 days
Drug: Meropenem or Imipenem
Meropenem or Imipenem 0.5 to 1 gram 3 to 4 times per day for 7 to 14 days
Other Names:
  • Tienam
  • Meronem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with cure or improvement
Time Frame: 14 days
Cure Improvement Persistence Death from Infection
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with eradication of the causative bacteria
Time Frame: 14 days
Eradication Persistence Superinfection
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Estimate)

January 2, 2012

Last Update Submitted That Met QC Criteria

December 29, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SirirajCEU 54-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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