Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)

PHASE3CompletedINTERVENTIONAL
Enrollment

467

Participants

Timeline

Start Date

October 6, 2012

Primary Completion Date

August 9, 2020

Study Completion Date

August 9, 2020

Conditions
PneumoniaBlood Stream Infection
Interventions
DRUG

colistin and meropenem

colistin standard loading dose, maintenance dose based on patients renal function meropenem- dose based on patients renal function

DRUG

colistin and placebo

colistin- loading dose standard, maintenance dosed based on patients renal function placebo- mimic meropenem (blinded)

Trial Locations (19)

1606

"University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov", Sofia

10029

Mount Sinai Hospital, New York

10676

Evangelismos General Hospital of Athens, Athens

10700

Siriraj Hospital, Bangkoknoi

11527

"General Hospital of Athens Laiko 1st Department of Medicine", Athens

12461

Attikon University General Hospital of Athens, Athens

31096

Rambam Health Care Campus, Haifa

33136

Jackson Memorial Hospital-Jackson Health System, Miami

33305

Chang Gung Memorial Hospital, Taoyuan District

43210

The Ohio State University Wexner Medical Center, Columbus

48073

Beaumont Health System, Royal Oak

48201

Wayne State University, Detroit

48202

Henry Ford Health System, Detroit

49100

Rabin Medical Centre, Beilinson Campus, Petah Tikva

54642

Hippokration General Hospital of Thessaloniki, Thessaloniki

64239

Tel-Aviv Sourasky Medical Center, Tel Aviv

70300

Assaf Harofeh Medical Center, Ẕerifin

71110

University Hospital of Heraklion, Crete

80131

Universita della Campania 'Luigi Vanvitelli', Naples

All Listed Sponsors
lead

University of Michigan

OTHER

NCT01597973 - Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME) | Biotech Hunter | Biotech Hunter