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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Administered intravenously over 3 hours
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.
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
...and 13 more locations
Number of Participants with Adverse Events in the Single Dose Phase
Time frame: 28 days
Maximum Observed Plasma Concentration (Cmax) of Cefiderocol in the Single Dose Phase
Time frame: Cohorts 1 and 2: Day 1 at 1, 3, 3.5, 5, and 8 hours after start of infusion. Cohorts 3 and 4: Day 1 at 3, 5, and 8 hours after the start of infusion.
Area Under the Plasma Concentration Time Curve Extrapolated From Time 0 to Infinity (AUCinf) of Cefiderocol in the Single Dose Phase
Time frame: Cohorts 1 and 2: Day 1 at 1, 3, 3.5, 5, and 8 hours after start of infusion. Cohorts 3 and 4: Day 1 at 3, 5, and 8 hours after the start of infusion.
Apparent Terminal Elimination Half-life of Cefiderocol in the Single Dose Phase
Time frame: Cohorts 1 and 2: Day 1 at 1, 3, 3.5, 5, and 8 hours after start of infusion. Cohorts 3 and 4: Day 1 at 3, 5, and 8 hours after the start of infusion.
Number of Participants with Adverse Events in the Multiple Dose Phase
Time frame: Up to 28 days after last dose (33 to 42 days depending on treatment duration)
Maximum Observed Plasma Concentration (Cmax) of Cefiderocol in the Multiple Dose Phase
Time frame: During one of the dosing intervals from the 6th to the 12th dose of cefiderocol: Cohort 2: at 1, 3, 3.5, 5, and 8 hours after start of infusion. Cohorts 3 and 4: at 3, 5, and 8 hours after start of infusion.
Area Under the Plasma Concentration Time Curve Extrapolated From Time 0 to Infinity (AUCinf) of Cefiderocol in the Multiple Dose Phase
Time frame: During one of the dosing intervals from the 6th to the 12th dose of cefiderocol: Cohort 2: at 1, 3, 3.5, 5, and 8 hours after start of infusion. Cohorts 3 and 4: at 3, 5, and 8 hours after start of infusion.
Apparent Terminal Elimination Half-life of Cefiderocol in the Multiple Dose Phase
Time frame: During one of the dosing intervals from the 6th to the 12th dose of cefiderocol: Cohort 2: at 1, 3, 3.5, 5, and 8 hours after start of infusion. Cohorts 3 and 4: at 3, 5, and 8 hours after start of infusion.
Percentage of Participants with a Clinical Response in the Multiple Dose Phase
Time frame: At 7 and 28 days after the end of treatment
Percentage of Participants with a Microbiological Response Per Pathogen in the Multiple Dose Phase
Time frame: At 7 and 28 days after the end of treatment
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