Ertapenem Versus Meropenem/Imipenem for ESBL+ Gram-negative Infections
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
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2011
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJanuary 2, 2012
December 1, 2011
1.9 years
February 14, 2011
December 29, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects with cure or improvement
Cure Improvement Persistence Death from Infection
14 days
Secondary Outcomes (1)
Number of subjects with eradication of the causative bacteria
14 days
Study Arms (2)
Ertapenem
EXPERIMENTALErtapenem 1 gram per day for 7 to 14 days
Meropenem or Imipenem
ACTIVE COMPARATORMeropenem or Imipenem o.5 or 1 gram 3 to 4 times a day for 7 to 14 days
Interventions
Meropenem or Imipenem 0.5 to 1 gram 3 to 4 times per day for 7 to 14 days
Eligibility Criteria
You may qualify if:
- Hospitalized patients aged \>18 years with documented ESBL +ve GNB infection
- Receive meropenem or imipenem/cilastatin as empiric antibiotic therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Siriraj Hospital
Bangkok, Bangkok, 10700, Thailand
Related Publications (1)
Rattanaumpawan P, Werarak P, Jitmuang A, Kiratisin P, Thamlikitkul V. Efficacy and safety of de-escalation therapy to ertapenem for treatment of infections caused by extended-spectrum-beta-lactamase-producing Enterobacteriaceae: an open-label randomized controlled trial. BMC Infect Dis. 2017 Mar 1;17(1):183. doi: 10.1186/s12879-017-2284-1.
PMID: 28249572DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Visanu Thamlikitkul, MD
Siriraj Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division of Infectious Diseases and tropical medicine, Department of medicine, Faculty of Medicine Siriraj Hospital.
Study Record Dates
First Submitted
February 14, 2011
First Posted
February 17, 2011
Study Start
May 1, 2011
Primary Completion
April 1, 2013
Study Completion
August 1, 2013
Last Updated
January 2, 2012
Record last verified: 2011-12