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

Mahidol University

Status and phase: Unknown; Phase 4

Conditions: Drug Safety

Treatments: Drug: Ertapenem; Drug: Meropenem or Imipenem

Study type: Interventional

Funder types: Other

Identifiers

NCT01297842

SirirajCEU 54-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Ertapenem

Experimental group

Description:

Ertapenem 1 gram per day for 7 to 14 days

Treatment:

Drug: Ertapenem

Meropenem or Imipenem

Active Comparator group

Description:

Meropenem or Imipenem o.5 or 1 gram 3 to 4 times a day for 7 to 14 days

Treatment:

Drug: Meropenem or Imipenem