NCT01297842

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Drug Safety

Interventions

Type	Name	Description
DRUG	Ertapenem	Ertapenem 1 gram per day for 7 to 14 days
DRUG	Meropenem or Imipenem	Meropenem or Imipenem 0.5 to 1 gram 3 to 4 times per day for 7 to 14 days

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-04-01
• Completion: 2013-08-01
• First posted: 2011-02-17
• Last updated: 2012-01-02

Locations

1 site across 1 country: Thailand