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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Visanu Thamlikitkul, Mahidol University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Visanu Thamlikitkul, Mahidol University Identifier:
First received: February 14, 2011
Last updated: December 29, 2011
Last verified: December 2011
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
Intervention Model: Parallel Assignment
Masking: None (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 Visanu Thamlikitkul, Mahidol University:

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

Secondary Outcome Measures:
  • Number of subjects with eradication of the causative bacteria [ Time Frame: 14 days ]
    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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01297842

Contact: Visanu Thamlikitkul, MD 6624125994

Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Visanu Thamlikitkul, MD    662-412-5994   
Principal Investigator: Visanu Thamlikitkul, MD         
Sponsors and Collaborators
Mahidol University
Principal Investigator: Visanu Thamlikitkul, MD Siriraj Hospital
  More Information

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

Additional relevant MeSH terms:
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 21, 2017