Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

August 6, 2023

Primary Completion Date

December 18, 2024

Study Completion Date

December 18, 2024

Conditions
Neonatal Sepsis
Interventions
DRUG

Ceftobiprole medocaril

Ceftobiprole medocaril: 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, administered IV as a 2-hour infusion.

Trial Locations (14)

1002

Pauls Stradins Clinical University Hospital, Riga

1004

Children Clinical University Hospital - Neonatology Clinic, Riga

1407

"Acibadem City Clinic University Hospital Tokuda EAD, Neonatology Department", Sofia

3400

MHAT Dr. Stamen Iliev AD Montana, Neonatology Department, Montana

4000

"UMHAT Sveti Georgi EAD, Pediatric surgery Clinic", Plovdiv

13419

Tallinn Childrens' Hospital, Tallinn

26506

West Virginia University, Morgantown

50161

Lithuanian Health Science University Hospital Kauno klinikos - Neonatology Clinic, Kaunas

60201

NorthShore University HealthSystem-Evanston Hospital, Evanston

80337

Klinikum der Universität München, Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital, Munich

08410

Vilnius University Hospital Santaros klinikos - Neonatology Center, Vilnius

60-535

Ginekologiczno-Położniczy Szpital Kliniczny im. Marcinkowskiego, Poznan

50-556

Szpital Uniwersytecki - Klinika Neonatologii, Wroclaw

03659

Univerzitna nemocnica Martin, Martin

Sponsors
All Listed Sponsors
lead

Basilea Pharmaceutica

INDUSTRY