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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297842
First Posted: February 17, 2011
Last Update Posted: January 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Visanu Thamlikitkul, Mahidol University
  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
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 14, 2011
First Posted: February 17, 2011
Last Update Posted: January 2, 2012
Last Verified: December 2011

Additional relevant MeSH terms:
Gram-Negative Bacterial Infections
Bacterial Infections
Meropenem
Thienamycins
Imipenem
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents