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A Single Arm, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Paediatric Subjects 3 Months to <18 Years of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections
The primary objectives of this study are: * To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to \< 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections * To assess the pharmacokinetics (PK) of cefiderocol after single-dose administration of cefiderocol in hospitalized paediatric participants 3 months to \< 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections * To assess the safety and tolerability of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections * To assess the PK of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections
This is a multicenter, single-arm, open-label, single- and multiple-dose study to assess the safety, tolerability, and PK of cefiderocol in hospitalized paediatric participants. The single-dose phase will include 4 separate cohorts of participants, grouped according to age range: * Cohort 1: 12 to \< 18 years * Cohort 2: 6 to \< 12 years * Cohort 3: 2 to \< 6 years * Cohort 4: 3 months to \< 2 years Cohorts 1, 2, and 3 in the single-dose phase will be initiated in parallel. Cohort 4 will begin after safety and PK data from at least 6 participants from the single-dose Cohorts 1, 2, and 3 (with a minimum of 3 participants from Cohort 3) have been assessed. The multiple-dose phase will include 3 cohorts according to age range (Cohorts 2, 3, and 4) and will begin after safety and PK data from 6 participants in the corresponding single-dose cohort have been assessed.
Age
0 - 17 years
Sex
ALL
Healthy Volunteers
No
Universitair Ziekenhuis Brussel
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Tallinn Childrens Hospital
Tallinn, Estonia
Tartu Ulikooli Kliinikum - Anestesioloogia ja Intensiivravi Kliinik
Tartu, Estonia
JSC "Medical Corporation Evex" " M. Iashvili Batumi Maternal and Child Central Hospital"
Batumi, Georgia
JSC "EVEX Medical Corporation"- M Lashvili Childrens Central Hospital
Tbilisi, Georgia
Ltd Unimedi Kakheti Childrens New Clinic
Tbilisi, Georgia
Heim Pl Orszgos Gyermekgygyszati Intzet
Pilisborosjenő, Hungary
Szegedi Tudomnyegyetem
Szegedi Tudomnyegyetem, Hungary
Daugavpils regional Hospital
Daugavpils, Latvia
Start Date
August 21, 2020
Primary Completion Date
February 6, 2023
Completion Date
February 6, 2023
Last Updated
February 27, 2026
53
ACTUAL participants
Cefiderocol
DRUG
Standard of Care
DRUG
Lead Sponsor
Shionogi
NCT06135350
NCT06086626
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04215991