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

This study is currently recruiting participants.
Verified December 2011 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Visanu Thamlikitkul, Mahidol University
ClinicalTrials.gov Identifier:
NCT01297842
First received: February 14, 2011
Last updated: December 29, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Drug Safety
 Drug: Ertapenem
Drug: Meropenem or Imipenem
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Number of subjects with cure or improvement [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Cure Improvement Persistence Death from Infection


Secondary Outcome Measures:
  • Number of subjects with eradication of the causative bacteria [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Eradication Persistence Superinfection


Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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:
  • Meronem
  • Tienam

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297842

Contacts
Contact: Visanu Thamlikitkul, MD 6624125994 sivth@mahidol.ac.th

Locations
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Visanu Thamlikitkul, MD     662-412-5994     sivth@mahidol.ac.th    
Principal Investigator: Visanu Thamlikitkul, MD            
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Visanu Thamlikitkul, MD Siriraj Hospital
  More Information

No publications provided

Responsible Party: Visanu Thamlikitkul, Division of Infectious Diseases and tropical medicine, Department of medicine, Faculty of Medicine Siriraj Hospital., Mahidol University
ClinicalTrials.gov Identifier: NCT01297842     History of Changes
Other Study ID Numbers: SirirajCEU 54-001
Study First Received: February 14, 2011
Last Updated: December 29, 2011
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Bacterial Infections
Gram-Negative Bacterial Infections
Imipenem
Meropenem
Ertapenem
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013