Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-02-28

Brief Summary

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The purpose of this study is to determine whether the addition of meropenem to colistin is better than colistin alone in the treatment of clinically significant infections caused by multi-drug resistant bacteria

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Detailed Description

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Conditions

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Gram-Negative Bacterial Infections

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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Colistin and Meropenem

IV meropenem, 2 gram q8h, adjusted for renal function IV Colistin with loading dose of 9 mil IU units, Maintenance dose 4.5 mil IU q12h, adjusted for renal function

Group Type EXPERIMENTAL

Colistin

Intervention Type DRUG

IV Colistin with loading dose of 9 mil IU units, Maintenance dose 4.5 mil IU q12h, adjusted for renal function, for 10 days.

Meropenem

Intervention Type DRUG

IV meropenem, 2 gram q8h, adjusted for renal function, for up to 10 days.

Colistin

IV Colistin with loading dose of 9 mil IU units, Maintenance dose 4.5 mil IU q12h, adjusted for renal function

Group Type ACTIVE_COMPARATOR

Colistin

Intervention Type DRUG

IV Colistin with loading dose of 9 mil IU units, Maintenance dose 4.5 mil IU q12h, adjusted for renal function, for 10 days.

Interventions

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Colistin

IV Colistin with loading dose of 9 mil IU units, Maintenance dose 4.5 mil IU q12h, adjusted for renal function, for 10 days.

Intervention Type DRUG

Meropenem

IV meropenem, 2 gram q8h, adjusted for renal function, for up to 10 days.

Intervention Type DRUG

Other Intervention Names

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Colistimethate Sodium Coliracin Meronem

Eligibility Criteria

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Inclusion Criteria

* Adult inpatients
* Clinically significant, microbiological-documented infection caused by carbapenem-resistant and colistin-susceptible Gram-negative bacteria and identified according to CDC criteria- blood stream infections, hospital acquired pneumonia, ventilator associated pneumonia, and urinary tract infections
* Patient recruitment will occur only after microbiological documentation and susceptibility testing. Patients will be included within 96 hours of the time the index culture was taken (typically within 48 hours of isolate identification), regardless of the antibiotic treatment administered during this time period.

Exclusion Criteria

* Previous inclusion in the trial. Patients will be included in the RCT only once for the first identified episode of infection
* Pregnant women
* Epilepsy or prior seizures
* Known allergy to colistin or a carbapenem

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No