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

Completed · Phase 2

Conditions studied: Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP), Complicated Urinary Tract Infection (cUTI), Ventilator Associated Bacterial Pneumonia (VABP)

In brief

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).

Key facts

Study ID: NCT04215991
Run by: Shionogi
People needed: 91
Starts: 2020-02-19
Expected to finish: 2024-09-17
Last updated by the study team: 2025-05-25

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant's parent(s) or legally authorized representative(s) (LAR) provides written informed consent in accordance with regional- and country-specific laws and regulations
Participant provides written informed assent, when feasible (age of assent to be determined by institutional review board/independent ethics committee [IRBs/IECs] or be consistent with local legal requirements)
Hospitalized participant is 3 months to < 18 years of age at the time written informed consent/assent is obtained for the multiple-dose phase. Hospitalized participant is 3 months to < 12 years of age at the time written informed consent/assent is obtained for the single-dose phase.
Single-dose phase: Participant has a suspected or confirmed infection type (including but not limited to cUTI, complicated intra-abdominal infections [cIAI], pneumonia, HABP/VABP, and sepsis or bloodstream infections [BSI]) that requires hospitalization for treatment with IV antibiotics.
Multiple-dose phase: Participant has a suspected or confirmed cUTI, HABP, or VABP that requires hospitalization for treatment with IV antibiotics
If participant is a sexually active female of childbearing potential and has reached menarche or Tanner stage 3, participant agrees to use barrier contraception (including condom, diaphragm, or cervical cap) with spermicide or agrees to use a highly effective method of contraception (including contraceptive implant, injectable contraceptive, combination oral contraceptive, or an intrauterine [IUD] contraceptive device) from Screening up to 28 days after administration of the last dose of cefiderocol.

You may not qualify if…

Participant has a documented history of any hypersensitivity or allergic reaction to any β-lactam antibiotic (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment.)
Multiple-dose only: Participant has an infection caused only by a confirmed Gram-positive pathogen.
Participant has a suspected or confirmed central nervous system (CNS) infection (for example, meningitis, brain abscess, shunt infection) or osteomyelitis (which would require prolonged antibiotic therapy).
Participant has cystic fibrosis.
Single-dose phase: Participant has moderate or severe renal impairment based on estimated glomerular filtration rate (eGFR) (based on the Schwartz equation if ≥ 3 months to < 1 year of age and modified Bedside Schwartz equation if ≥ 1 to < 18 years of age) of < 60 milliliter (mL)/ minute (min)/1.73 square meters (m\^2)² at Screening .
Multiple-dose phase: Participant has an eGFR (based on the Schwartz equation if ≥ 3 months to < 1 year of age and modified Bedside Schwartz equation if ≥ 1 to < 18 years of age) of < 15 mL/min/1.73 m² at Screening.
Participant has end-stage renal disease (ESRD), is on hemodialysis (HD), or receiving continuous venovenous hemofiltration (CVVH).
Participant has experienced shock in the prior month or is in shock at the time of Screening.
Participant has severe neutropenia or is severely immunocompromised.
Participant has multiorgan failure .
Participant with a life expectancy of < 30 days due to severity of a concurrent illness.
Participant is a female who has a positive pregnancy test at Screening.
Participant is a female who is breastfeeding.
Participant has received any other investigational medicinal product (IMP) within 30 days.
Participant has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data, including acute trauma to the pelvis or urinary tract.
Participant is receiving vasopressor therapy at Screening.

Where it is running

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
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
Hospital of Lithuanian University of Health Sciences Kauno klinikos — Kaunas, Lithuania
Klaipeda Children's Hospital — Klaipėda, Lithuania
Vilnius University Hospital Santaros Klinikos — Vilnius, Lithuania
Hospital Civil de Guadalajara Hospital 278, El retiro, Torre Piso 10, Infectología Ped. — Guadalajara, Jalisco, Mexico
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, Mexico
Hospital de Especialidades Ped Via España y Calle Zarak — Panama City, Panama
Hospital del Niño, Epidemiologia — Panama City, Panama
Chong Hua Hospital — Cebu City, Philippines
Western Visayas and Medical Center — Iloilo City, Philippines
Manila Doctor's Hospital — Manila, Philippines
Hospital Val d'Hebron — Barcelona, Spain
Hospital del Mar, Passeig Marítim 25-29 — Barcelona, Spain
Municipal Noncommercial Enterprise of Kharkiv Regional Council " V.I.Shapoval Regional Clinical Center of Urology and Nephrology", Department of Children Urology # 7 — Kharkiv, Ukraine
Vinnytsia Regional Children's Hospital — Vinnytsia, Ukraine
Zaporizhzhia Regional Children Clinical Hospital — Zaporizhzhya, Ukraine

Full record on ClinicalTrials.gov

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