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

PHASE4CompletedINTERVENTIONAL
Enrollment

406

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

January 31, 2017

Study Completion Date

February 28, 2017

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.

Trial Locations (7)

Unknown

Atikkon Hospital, Athens

Laikon Hosptial, Athens

Rambam Health Care Center, Haifa

Rabin Medical Center, Petach-Tikvah

Tel-Aviv Sourasky Medical Center, Tel Aviv

Monaldi Hospital, University of Naples S.U.N., Naples

Agostino Gemelli Hospital, Rome

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

European Commission

OTHER

lead

Mical Paul

OTHER

NCT01732250 - Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem | Biotech Hunter | Biotech Hunter