Ertapenem Versus Meropenem/Imipenem for ESBL+ Gram-negative Infections
- Registration Number
- NCT01297842
- Lead Sponsor
- Mahidol University
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meropenem or Imipenem Meropenem or Imipenem Meropenem or Imipenem o.5 or 1 gram 3 to 4 times a day for 7 to 14 days Ertapenem Ertapenem Ertapenem 1 gram per day for 7 to 14 days
- Primary Outcome Measures
Name Time Method Number of subjects with cure or improvement 14 days Cure Improvement Persistence Death from Infection
- Secondary Outcome Measures
Name Time Method Number of subjects with eradication of the causative bacteria 14 days Eradication Persistence Superinfection
Trial Locations
- Locations (1)
Siriraj Hospital
🇹🇭Bangkok, Thailand