Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics

PHASE1TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 22, 2016

Primary Completion Date

February 25, 2020

Study Completion Date

February 25, 2020

Conditions
Bacterial Infections
Interventions
DRUG

Ceftobiprole medocaril

Ceftobiprole medocaril was administered as a single intravenous infusion, with a bodyweight-adjusted volume, at a constant rate over 4 hours. The ceftobiprole dose was 7.5 mg/kg, which corresponds to 10.0 mg ceftobiprole medocaril.

Trial Locations (14)

15224

University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital, Pittsburgh

27705

Duke University Hospital, Durham

40202

Norton Children's Hospital, Louisville

46601

Beacon Children's Hospital, South Bend

77030

The University of Texas Health Science Center at Houston, Houston

90089

University of Southern California, Los Angeles

90095

University of California Los Angeles, Los Angeles

92354

Loma Linda University Medical Center, Loma Linda

26506-9214

West Virginia University School of Medicine, Morgantown

Unknown

UZ Leuven, Leuven

Klinikum der Universität München, Munich

Children Clinical University Hospital, Riga

Vilnius University Children's Hospital, Vilnius

University Children's Hospital of Kraków, Krakow

Sponsors
All Listed Sponsors
lead

Basilea Pharmaceutica

INDUSTRY