A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants

PHASE2CompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

February 19, 2020

Primary Completion Date

September 17, 2024

Study Completion Date

September 17, 2024

Conditions
Gram-negative Bacterial InfectionsHospital Acquired Bacterial Pneumonia (HABP)Complicated Urinary Tract Infection (cUTI)Ventilator Associated Bacterial Pneumonia (VABP)
Interventions
DRUG

Cefiderocol

Administered intravenously over 3 hours

DRUG

Standard of Care

Standard of care administered will be selected by the investigator based on the suspected or confirmed pathogen(s) for the infection in accordance with local standards.

Trial Locations (25)

1000

Manila Doctor's Hospital, Manila

4101

Queensland Children's Health Precinct Level 8, Centre for Children's Health Research 62 Graham Street, South Brisbane

4530

"Instituto Nacional de Pediatría Laboratorio de la Unidad de Apoyo a la Investigación Clínica, Planta Baja Col. Insurgentes Cuicuilco, Delegacion Coyoacán Av. Insurgentes Sur 3700-C", Mexico City

5000

Western Visayas and Medical Center, Iloilo City

6000

Chong Hua Hospital, Cebu City

7110

Heraklion University General Hospital, Heraklion

8003

Hospital del Mar, Passeig Marítim 25-29, Barcelona

12462

"University Hospital ATTIKON 3rd Pediatric Clinic of NKUA", Chaïdári

21000

Vinnytsia Regional Children's Hospital, Vinnytsia

41110

University General Hospital of Larissa, Larissa

44280

Hospital Civil de Guadalajara Hospital 278, El retiro, Torre Piso 10, Infectología Ped., Guadalajara

52242

University of Iowa Stead Family Children's Hospital, Iowa City

54642

Hippokration Hospital 3rd Pediatric Clinic of AUTH Konstantinoupoleos 49, Thessaloniki

56403

General Hospital of Thessaloniki Papageorgiou, Thessaloniki

61037

"Municipal Noncommercial Enterprise of Kharkiv Regional Council V.I.Shapoval Regional Clinical Center of Urology and Nephrology, Department of Children Urology # 7", Kharkiv

69063

Zaporizhzhia Regional Children Clinical Hospital, Zaporizhzhia

76104

Cook Children's Medical Center, Fort Worth

0159

"JSC EVEX Medical Corporation- M Lashvili Childrens Central Hospital", Tbilisi

Ltd Unimedi Kakheti Childrens New Clinic, Tbilisi

LT-50161

Hospital of Lithuanian University of Health Sciences Kauno klinikos, Kaunas

LT-92140

Klaipeda Children's Hospital, Klaipėda

LT-08406

Vilnius University Hospital Santaros Klinikos, Vilnius

0801

Hospital de Especialidades Ped Via España y Calle Zarak, Panama City

0816-00383

Hospital del Niño, Epidemiologia, Panama City

08035

Hospital Val d'Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shionogi

INDUSTRY