138
Participants
Start Date
November 27, 2017
Primary Completion Date
March 16, 2020
Study Completion Date
March 16, 2020
ceftobiprole medocaril
"Ceftobiprole medocaril was administered at age-adjusted doses (10, 15 or 20 mg/kg) and infusion durations (2 or 4 hours) every 8 hours. The maximum dose, regardless of body weight, was 500 mg ceftobiprole every 8 hours (maximum total daily dose of 1500 mg ceftobiprole).~After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment."
IV standard-of-care cephalosporin
"Ceftriaxone was administered at 50 to 80 mg/kg IV as a single daily dose, up to a maximum dose of 2 g/day. The actual dose of ceftriaxone within this dose range was determined by the blinded investigator prior to first study drug administration and was not modified during subsequent study days.~After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment.~At the discretion of the blinded investigator, patients received vancomycin at a dose of 10 to 15 mg/kg IV every 6 hours, up to a maximum dose of 2 g/day, in addition to the IV standard-of-care cephalosporin when MRSA was suspected or confirmed."
Semmelweis University, Budapest
Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases, Budapest
"University Multiprofile Hospital for Active Treatment Aleksandrovska", Sofia
Torokbalint Pulmonology Institute, Törökbálint
"University Multiprofile Hospital for Active Treatment Sveti Georgi", Plovdiv
Bekes County Central Hospital, Gyula
"University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski", Pleven
Principal SMO Ltd., Baja
Multiprofile Hospital for Active Treatment, Rousse
Fejer County St. Gyorgy University Teaching Hospital, Székesfehérvár
Kanizsai Dorottya Hospital, Nagykanizsa
"Sf. Maria Children's Emergency Clinical Hospital", Iași
Amtel Hospital First Clinical LLC, Tbilisi
LTD High Technology Medical Center University Clinic, Tbilisi
JSC Evex Hospitals 1, Tbilisi
JSC Evex Hospitals 2, Tbilisi
Tbilisi State Medical University G. Zhvania Pediatric Academic Clinic, Tbilisi
Ltd Tbilisi Pediatric Private Clinic, Tbilisi
Alessandrescu-Rusescu National Institute for Mother and Child Health, Bucharest
Lead Sponsor
Basilea Pharmaceutica
INDUSTRY