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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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

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Drug Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ertapenem

Ertapenem 1 gram per day for 7 to 14 days

Group Type EXPERIMENTAL

Ertapenem

Intervention Type DRUG

Ertapenem 1 gram per day for 7 to 14 days

Meropenem or Imipenem

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

Group Type ACTIVE_COMPARATOR

Meropenem or Imipenem

Intervention Type DRUG

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

Interventions

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Ertapenem

Ertapenem 1 gram per day for 7 to 14 days

Intervention Type DRUG

Meropenem or Imipenem

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

Intervention Type DRUG

Other Intervention Names

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Invanz Meronem Tienam

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No