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

NCT01732250 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2017-04-12

No results posted yet for this study

Summary

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

Conditions

  • Gram-Negative Bacterial Infections

Interventions

DRUG

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.

DRUG

Meropenem

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

Sponsors & Collaborators

Principal Investigators

  • Johan Mouton, MD PhD · Radboud University Medical Center

  • Mical Paul, MD · Rambam Health Care Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2017-01-31
Completion
2017-02-28

Countries

  • Greece
  • Israel
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01732250 on ClinicalTrials.gov