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