The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric participants 3 months to \< 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP).
This study consists of a nonrandomized single-dose phase in children aged 3 months to less than 12 years with suspected or confirmed aerobic Gram-negative bacterial infections and a randomized multiple-dose, active-comparator standard of care (SOC) phase in children aged 3 months to less than 18 years with cUTI, HABP, or VABP to assess the PK, safety, and tolerability of cefiderocol in hospitalized participants requiring systemic antibiotics for an expected 5 to 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Administered intravenously over 3 hours
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.
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Queensland Children's Health Precinct Level 8, Centre for Children's Health Research 62 Graham Street
South Brisbane, Queensland, Australia
JSC "EVEX Medical Corporation"- M Lashvili Childrens Central Hospital
Tbilisi, Georgia
Ltd Unimedi Kakheti Childrens New Clinic
Tbilisi, Georgia
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: Day 1, 1 (cohort 2 only), 3, 3.5 (cohort 2 only), 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: Day 1, 1 (cohort 2 only), 3, 3.5 (cohort 2 only), 5, and 8 hours after the start of infusion
Apparent Terminal Elimination Half-life of Cefiderocol in the Single Dose Phase
Time frame: Day 1, 1 (cohort 2 only), 3, 3.5 (cohort 2 only), 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 of Cefiderocol in the Multiple Dose Phase
Time frame: During one of the dosing intervals from Day 5-14, 1 (cohort 2 1 and 2 only), 3, 3.5 (cohorts 1 and 2 only), 5, and 8 hours after the start of infusion
Area Under the Plasma Concentration Time Curve Over the Dosing Interval τ (AUC0-τ) of Cefiderocol in the Multiple Dose Phase
Time frame: During one of the dosing intervals from Day 5-14, 1 (cohort 2 1 and 2 only), 3, 3.5 (cohorts 1 and 2 only), 5, and 8 hours after the start of infusion
Apparent Terminal Elimination Half-life of Cefiderocol in the Multiple Dose Phase
Time frame: During one of the dosing intervals from Day 5-14, 1 (cohort 2 1 and 2 only), 3, 3.5 (cohorts 1 and 2 only), 5, and 8 hours after the start of infusion
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Heraklion University General Hospital
Heraklion, Crete, Greece
University General Hospital of Larissa
Larissa, Thessaly, Greece
University Hospital "ATTIKON" 3rd Pediatric Clinic of NKUA
Chaïdári, Greece
Hippokration Hospital 3rd Pediatric Clinic of AUTH Konstantinoupoleos 49
Thessaloniki, Greece
General Hospital of Thessaloniki Papageorgiou
Thessaloniki, Greece
...and 15 more locations