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

PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

August 21, 2020

Primary Completion Date

February 6, 2023

Study Completion Date

February 6, 2023

Conditions
Gram-negative Bacterial InfectionsBloodstream Infections (BSI)Complicated Intra-abdominal Infection (cIAI)Hospital Acquired Pneumonia (HAP)Ventilator-acquired PneumoniaComplicated Urinary Tract Infection (cUTI)Sepsis
Interventions
DRUG

Cefiderocol

Administered intravenously over 3 hours

DRUG

Standard of Care

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

Trial Locations (23)

1200

Universitair Ziekenhuis Brussel, Brussels

Unknown

Cliniques Universitaires Saint-Luc, Brussels

Tallinn Childrens Hospital, Tallinn

Tartu Ulikooli Kliinikum - Anestesioloogia ja Intensiivravi Kliinik, Tartu

"JSC Medical Corporation Evex M. Iashvili Batumi Maternal and Child Central Hospital", Batumi

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

Ltd Unimedi Kakheti Childrens New Clinic, Tbilisi

Heim Pl Orszgos Gyermekgygyszati Intzet, Pilisborosjenő

Szegedi Tudomnyegyetem, Szegedi Tudomnyegyetem

Daugavpils regional Hospital, Daugavpils

Bernu Kliniska Universitates Slimnica Childrens Hospital - Tornakalna, Riga

St. Petersburg State Pediatric Medical University, Saint Petersburg

Smolensk State Medical University, Smolensk

Hospital Germans Trias i Pujol, Barcelona

Hospital Universitario y Politecnico La Fe, Valencia

King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok

Siriraj Hospital, Bangkok Noi

PHPT-Chiangrai PrachanuKroh Hospital, Chiang Mai

Khon Kaen University (KKU) - Faculty of Medicine-Srinagarind Hospital, Khon Kaen

Dnipropetrovsk Regional Children Clinical Hospital, Kharkiv

Regional Children Clinical Hospital, Kharkiv

National Childrens Specialized Hospital OHMATDYT of the Ministry of Health of Ukraine, Kiev

Higher State Educational Institute of Ukraine Ukrainian Medical Stamatological Academy, Poltava

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shionogi

INDUSTRY