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

Drug Safety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01297842
• Other study ID #: SirirajCEU 54-001
• Status: Recruiting
• Phase: Phase 4
• First received: February 14, 2011
• Last updated: December 29, 2011
• Start date: May 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2011
• Source: Mahidol University
• Contact: Visanu Thamlikitkul, MD
• Phone: 6624125994
• Email: sivth[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Drug Safety
• Gram-Negative Bacterial Infections

Intervention

Drug:
• Ertapenem
Ertapenem 1 gram per day for 7 to 14 days
• Meropenem or Imipenem
Meropenem or Imipenem 0.5 to 1 gram 3 to 4 times per day for 7 to 14 days

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with cure or improvement	Cure Improvement Persistence Death from Infection	14 days	Yes
Secondary	Number of subjects with eradication of the causative bacteria	Eradication Persistence Superinfection	14 days	No