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

Last updated: November 15, 2024
Sponsor: Shionogi
Overall Status: Completed

Phase

2

Condition

Pneumonia

Urinary Tract Infections

Bacterial Infections

Treatment

Standard of Care

Cefiderocol

Clinical Study ID

NCT04215991
1704R2133
2019-002121-30
  • Ages 3-17
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant's parent(s) or legally authorized representative(s) (LAR) provideswritten informed consent in accordance with regional- and country-specific laws andregulations

  2. Participant provides written informed assent, when feasible (age of assent to bedetermined by institutional review board/independent ethics committee [IRBs/IECs] orbe consistent with local legal requirements)

  3. Hospitalized participant is 3 months to < 18 years of age at the time writteninformed consent/assent is obtained for the multiple-dose phase. Hospitalizedparticipant is 3 months to < 12 years of age at the time written informedconsent/assent is obtained for the single-dose phase.

  4. 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 requireshospitalization for treatment with IV antibiotics. Multiple-dose phase: Participant has a suspected or confirmed cUTI, HABP, or VABPthat requires hospitalization for treatment with IV antibiotics

  5. If participant is a sexually active female of childbearing potential and has reachedmenarche or Tanner stage 3, participant agrees to use barrier contraception (including condom, diaphragm, or cervical cap) with spermicide or agrees to use ahighly 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 lastdose of cefiderocol.

Exclusion

Exclusion Criteria:

  1. Participant has a documented history of any hypersensitivity or allergic reaction toany β-lactam antibiotic (Note: for β-lactams, a history of a mild rash followed byuneventful re-exposure is not a contraindication to enrollment.)

  2. Multiple-dose only: Participant has an infection caused only by a confirmedGram-positive pathogen.

  3. Participant has a suspected or confirmed central nervous system (CNS) infection (forexample, meningitis, brain abscess, shunt infection) or osteomyelitis (which wouldrequire prolonged antibiotic therapy).

  4. Participant has cystic fibrosis.

  5. Single-dose phase: Participant has moderate or severe renal impairment based onestimated glomerular filtration rate (eGFR) (based on the Schwartz equation if ≥ 3months to < 1 year of age and modified Bedside Schwartz equation if ≥ 1 to < 18years of age) of < 60 milliliter (mL)/ minute (min)/1.73 square meters (m^2)² atScreening . Multiple-dose phase: Participant has an eGFR (based on the Schwartz equation if ≥ 3months to < 1 year of age and modified Bedside Schwartz equation if ≥ 1 to < 18years of age) of < 15 mL/min/1.73 m² at Screening.

  6. Participant has end-stage renal disease (ESRD), is on hemodialysis (HD), orreceiving continuous venovenous hemofiltration (CVVH).

  7. Participant has experienced shock in the prior month or is in shock at the time ofScreening.

  8. Participant has severe neutropenia or is severely immunocompromised.

  9. Participant has multiorgan failure .

  10. Participant with a life expectancy of < 30 days due to severity of a concurrentillness.

  11. Participant is a female who has a positive pregnancy test at Screening.

  12. Participant is a female who is breastfeeding.

  13. Participant has received any other investigational medicinal product (IMP) within 30days.

  14. Participant has any condition or circumstance that, in the opinion of theinvestigator, would compromise the safety of the participant or the quality of thestudy data, including acute trauma to the pelvis or urinary tract.

  15. Participant is receiving vasopressor therapy at Screening.

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Standard of Care
Phase: 2
Study Start date:
February 19, 2020
Estimated Completion Date:
September 17, 2024

Study Description

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.

Connect with a study center

  • Queensland Children's Health Precinct Level 8, Centre for Children's Health Research 62 Graham Street

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Queensland Children's Health Precinct Level 8, Centre for Children's Health Research 62 Graham Street

    South Brisbane Queensland, 4101
    Australia

    Site Not Available

  • JSC "EVEX Medical Corporation"- M Lashvili Childrens Central Hospital

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Ltd Unimedi Kakheti Childrens New Clinic

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Heraklion University General Hospital

    Heraklion, Crete 7110
    Greece

    Site Not Available

  • University General Hospital of Larissa

    Larissa, Thessaly 41110
    Greece

    Site Not Available

  • University Hospital "ATTIKON" 3rd Pediatric Clinic of NKUA

    Chaidari, 12462
    Greece

    Site Not Available

  • Heraklion University General Hospital

    Heraklion, Crete, 7110
    Greece

    Site Not Available

  • General Hospital of Thessaloniki Papageorgiou

    Thessaloniki, 56403
    Greece

    Site Not Available

  • Hippokration Hospital 3rd Pediatric Clinic of AUTH Konstantinoupoleos 49

    Thessaloniki, 54642
    Greece

    Site Not Available

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, LT-50161
    Lithuania

    Site Not Available

  • Klaipeda Children's Hospital

    Klaipeda, LT-92140
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT-08406
    Lithuania

    Site Not Available

  • Hospital Civil de Guadalajara Hospital 278, El retiro, Torre Piso 10, Infectología Ped.

    Guadalajara, Jalisco 44280
    Mexico

    Site Not Available

  • 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

    Ciudad de México, 4530
    Mexico

    Site Not Available

  • Hospital Civil de Guadalajara Hospital 278, El retiro, Torre Piso 10, Infectología Ped.

    Guadalajara Jalisco, 44280
    Mexico

    Site Not Available

  • Hospital de Especialidades Ped Via España y Calle Zarak

    Ciudad de Panama, 0801
    Panama

    Site Not Available

  • Hospital del Niño, Epidemiologia

    Panama City, 0816-00383
    Panama

    Site Not Available

  • Chong Hua Hospital

    Cebu City, 6000
    Philippines

    Site Not Available

  • Western Visayas and Medical Center

    Iloilo City, 5000
    Philippines

    Site Not Available

  • Western Visayas and Medical Center

    Jaro Iloilo City, 5000
    Philippines

    Site Not Available

  • Manila Doctor's Hospital

    Manila, 1000
    Philippines

    Site Not Available

  • Manila Doctors' Hospital

    Metro Manila, 1000
    Philippines

    Site Not Available

  • Hospital Val d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital del Mar, Passeig Marítim 25-29

    Barcelona, 8003
    Spain

    Site Not Available

  • Municipal Noncommercial Enterprise of Kharkiv Regional Council " V.I.Shapoval Regional Clinical Center of Urology and Nephrology", Department of Children Urology # 7

    Kharkiv, 61037
    Ukraine

    Site Not Available

  • Municipal Noncommercial Enterprise of Kharkiv Regional Council " V.I.Shapoval Regional Clinical Center of Urology and Nephrology",Department of Children Urology # 7

    Kharkiv, 61037
    Ukraine

    Site Not Available

  • Vinnytsia Regional Children's Hospital

    Vinnytsia, 21000
    Ukraine

    Site Not Available

  • Vinnytsa Regional Children's Hospital

    Vynnytsia, 21000
    Ukraine

    Site Not Available

  • Zaporizhzhia Regional Children Clinical Hospital

    Zaporizhzhia, 69063
    Ukraine

    Site Not Available

  • University of Iowa Stead Family Children's Hospital

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

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