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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Mahidol University.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 30, 2014