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

Mical Paul

Status and phase: Completed; Phase 4

Conditions: Gram-Negative Bacterial Infections

Treatments: Drug: Colistin; Drug: Meropenem

Study type: Interventional

Funder types: Other

Identifiers

NCT01732250

0276-12-RMC

Details and patient eligibility

About

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

Enrollment: 406 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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406 participants in 2 patient groups

Colistin and Meropenem

Experimental group

Description:

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

Treatment:

Drug: Meropenem

Drug: Colistin

Colistin

Active Comparator group

Description:

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

Treatment:

Drug: Colistin