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

Mahidol University100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Drug Safety

Interventions

ErtapenemDRUG

Ertapenem 1 gram per day for 7 to 14 days

Meropenem or ImipenemDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Siriraj Hospital

Bangkok, Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

Number of subjects with cure or improvement

Cure Improvement Persistence Death from Infection

Time frame: 14 days

Secondary Outcomes

Number of subjects with eradication of the causative bacteria

Eradication Persistence Superinfection

Time frame: 14 days

Central Contacts

Visanu Thamlikitkul, MD

CONTACT

6624125994 sivth@mahidol.ac.th

Data from ClinicalTrials.gov

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