Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia

PHASE3CompletedINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

November 27, 2017

Primary Completion Date

March 16, 2020

Study Completion Date

March 16, 2020

Conditions
Community-acquired Pneumonia (CAP)Hospital-acquired Pneumonia (HAP)
Interventions
DRUG

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."

DRUG

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."

Trial Locations (19)

1094

Semmelweis University, Budapest

1097

Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases, Budapest

1431

"University Multiprofile Hospital for Active Treatment Aleksandrovska", Sofia

2045

Torokbalint Pulmonology Institute, Törökbálint

4002

"University Multiprofile Hospital for Active Treatment Sveti Georgi", Plovdiv

5700

Bekes County Central Hospital, Gyula

5800

"University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski", Pleven

6500

Principal SMO Ltd., Baja

7002

Multiprofile Hospital for Active Treatment, Rousse

8000

Fejer County St. Gyorgy University Teaching Hospital, Székesfehérvár

8800

Kanizsai Dorottya Hospital, Nagykanizsa

700309

"Sf. Maria Children's Emergency Clinical Hospital", Iași

0144

Amtel Hospital First Clinical LLC, Tbilisi

LTD High Technology Medical Center University Clinic, Tbilisi

0159

JSC Evex Hospitals 1, Tbilisi

JSC Evex Hospitals 2, Tbilisi

Tbilisi State Medical University G. Zhvania Pediatric Academic Clinic, Tbilisi

0191

Ltd Tbilisi Pediatric Private Clinic, Tbilisi

020395

Alessandrescu-Rusescu National Institute for Mother and Child Health, Bucharest

Sponsors
All Listed Sponsors
lead

Basilea Pharmaceutica

INDUSTRY

NCT03439124 - Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia | Biotech Hunter | Biotech Hunter