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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01297842
Other study ID # SirirajCEU 54-001
Secondary ID
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


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
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