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Trials / Completed

CompletedNCT01732250

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

Multicenter Open-label RCT to Compare Colistin Alone vs. Colistin Plus Meropenem

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
406 (actual)
Sponsor
Mical Paul · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGColistinIV Colistin with loading dose of 9 mil IU units, Maintenance dose 4.5 mil IU q12h, adjusted for renal function, for 10 days.
DRUGMeropenemIV meropenem, 2 gram q8h, adjusted for renal function, for up to 10 days.

Timeline

Start date
2013-03-01
Primary completion
2017-01-31
Completion
2017-02-28
First posted
2012-11-22
Last updated
2017-04-12

Locations

7 sites across 3 countries: Greece, Israel, Italy

Source: ClinicalTrials.gov record NCT01732250. Inclusion in this directory is not an endorsement.

Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem (NCT01732250) · Clinical Trials Directory