DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Safety

Intervention: Ertapenem (Drug); Meropenem or Imipenem (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Visanu Thamlikitkul, MD, Principal Investigator, Affiliation: Siriraj Hospital

Overall contact:
Visanu Thamlikitkul, MD, Phone: 6624125994, Email: sivth@mahidol.ac.th


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of subjects with cure or improvement

Secondary outcome: Number of subjects with eradication of the causative bacteria

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Visanu Thamlikitkul, MD, Phone: 6624125994, Email: sivth@mahidol.ac.th

Siriraj Hospital, Bangkok 10700, Thailand; Recruiting
Visanu Thamlikitkul, MD, Phone: 662-412-5994, Email: sivth@mahidol.ac.th
Visanu Thamlikitkul, MD, Principal Investigator
Additional Information

Starting date: May 2011
Last updated: December 29, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017