330
Participants
Start Date
May 31, 2015
Primary Completion Date
August 31, 2016
Study Completion Date
September 30, 2016
Debio 1450 IV
Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).
Debio 1450 Oral
Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).
Linezolid
Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.
Debio 1450 Oral Placebo
Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.
Linezolid Placebo
Linezolid placebo will be supplied as film-coated compressed tablets.
Vancomycin IV
Vancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.
Columbus Regional Research, Columbus
Shands Burn Center at the University of Florida, Gainesville
Central Florida Internists, Orlando
Triple O Research Institute, West Palm Beach
ID Clinical Research, Ltd., Toledo
Beaumont Infectious Disease Services, Royal Oak
Mercury Street Medical Group PLLC, Butte
East Montgomery County Clinic, Houston
Tidwell Medical Center, Splendora
eStudySite - Las Vegas, Las Vegas
Southbay Pharma Research, Buena Park
Long Beach Clinical Trials LLC, Long Beach
Alliance Research, Long Beach
Olive View - UCLA Medical Center, Sylmar
Dream Team Clinical Research, LLC, Anaheim
eStudySite - Chula Vista, Chula Vista
eStudySite - La Mesa, La Mesa
eStudySite - Oceanside, Oceanside
Physician Alliance Research Center, Anaheim
Central Valley Research, LLC, Modesto
South Jersey Infectious Disease, Somers Point
Holy Name Medical Center, Teaneck
Lead Sponsor
Debiopharm International SA
INDUSTRY