679
Participants
Start Date
February 19, 2018
Primary Completion Date
April 22, 2019
Study Completion Date
April 22, 2019
ceftobiprole medocaril
ceftobiprole 500 mg was to be administered every 8 hours as a 2-hour IV infusion (with dose adjustment for renal impairment). The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor.
vancomycin+aztreonam
"Vancomycin 1000 mg (or 15 mg/kg) was to be administered every 12 hours (with dose adjustment for renal impairment) as 2-hour IV infusion. Vancomycin dose adjustment for morbidly obese and hypermetabolic patients was to be done according to local standard of care. When locally available, vancomycin trough testing (VTT) might have been used by the unblinded pharmacist or delegate to adjust the vancomycin dose. The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor.~Aztreonam 1000 mg was to be administered as a 0.5-hour IV infusion every 12 hours. If CLCR was \< 30 mL/min (i.e., severe renal impairment), the aztreonam dosage regimen was to be adjusted. The requirement to continue aztreonam therapy beyond Day 3 was to be reassessed at the 72-hour study visit."
"University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov, Clinic of Purulent-Septic Surgery-N.I. Pirogov", Sofia
CRU Hungary Ltd., Miskolc
University Multiprofile Hospital for Active Treatment, Plovdiv
University Multiprofile Hospital for Active Treatment, Pleven
University of SzegednAlbert Szent-Gyorgyi Clinical Center, Szeged
University Multiprofile Hospital for Active Treatment, Rousse
Kaposi Mor Teaching Hospital, Kaposvár
Csolnoky Ferenc Hospital, Veszprém
Central District Hospital, Zhytomyr
Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Vinnytsia
Gonzalez MD and Aswad MD Health Services, Coral Gables
L&C Professional Medical Research Institute, Miami
Dnipropetrovsk I.I. Mechnуkov Regional Clinical Hospital, Surgery Department #2, Dnipro
Mercury Street Medical Group, Butte
Zaporizhia City Clinical Hospital of Urgent and Emergency Medical Care, Zaporizhia
Ivano-Frankivsk City Clinical Hospital Surgery 1, Ivano-Frankivsk
Ivano-Frankivsk City Clinical Hospital General Surgery, Ivano-Frankivsk
Public City Clinical Hospital of Emergency Medical Care, Lviv
Lviv Regional Clinical Hospital, Lviv
Central City Clinical Hospital, Uzhhorod
eStudySite - Las Vegas - PPDS, Las Vegas
Excel Clinical Research, Las Vegas
Omnibus Clinical Research, La Palma
Alliance Research LLC, Long Beach
Long Beach Clinical Trials, Long Beach
eStudySite - Chula Vista - PPDS, Chula Vista
eStudySite - La Mesa - PPDS, La Mesa
Marvel Clinical Research, Huntington Beach
Physician Alliance Research Center, Anaheim
Saint Joseph's Clinical Research, Anaheim
Central Valley Research LLC, Fresno
Central Valley Research, LLC, Modesto
South Jersey Infectious Disease, Somers Point
Kyiv City Clinical Hospital, Kyiv
Lead Sponsor
Basilea Pharmaceutica
INDUSTRY