Phase
Condition
Pneumonia
Urinary Tract Infections
Bacterial Infections
Treatment
Standard of Care
Cefiderocol
Clinical Study ID
Ages 3-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant's parent(s) or legally authorized representative(s) (LAR) provideswritten informed consent in accordance with regional- and country-specific laws andregulations
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)
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.
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
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:
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.)
Multiple-dose only: Participant has an infection caused only by a confirmedGram-positive pathogen.
Participant has a suspected or confirmed central nervous system (CNS) infection (forexample, meningitis, brain abscess, shunt infection) or osteomyelitis (which wouldrequire prolonged antibiotic therapy).
Participant has cystic fibrosis.
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.
Participant has end-stage renal disease (ESRD), is on hemodialysis (HD), orreceiving continuous venovenous hemofiltration (CVVH).
Participant has experienced shock in the prior month or is in shock at the time ofScreening.
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 concurrentillness.
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 30days.
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.
Participant is receiving vasopressor therapy at Screening.
Study Design
Study Description
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
AustraliaSite Not Available
Queensland Children's Health Precinct Level 8, Centre for Children's Health Research 62 Graham Street
South Brisbane Queensland, 4101
AustraliaSite Not Available
JSC "EVEX Medical Corporation"- M Lashvili Childrens Central Hospital
Tbilisi, 0159
GeorgiaSite Not Available
Ltd Unimedi Kakheti Childrens New Clinic
Tbilisi, 0159
GeorgiaSite Not Available
Heraklion University General Hospital
Heraklion, Crete 7110
GreeceSite Not Available
University General Hospital of Larissa
Larissa, Thessaly 41110
GreeceSite Not Available
University Hospital "ATTIKON" 3rd Pediatric Clinic of NKUA
Chaidari, 12462
GreeceSite Not Available
Heraklion University General Hospital
Heraklion, Crete, 7110
GreeceSite Not Available
General Hospital of Thessaloniki Papageorgiou
Thessaloniki, 56403
GreeceSite Not Available
Hippokration Hospital 3rd Pediatric Clinic of AUTH Konstantinoupoleos 49
Thessaloniki, 54642
GreeceSite Not Available
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, LT-50161
LithuaniaSite Not Available
Klaipeda Children's Hospital
Klaipeda, LT-92140
LithuaniaSite Not Available
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08406
LithuaniaSite Not Available
Hospital Civil de Guadalajara Hospital 278, El retiro, Torre Piso 10, Infectología Ped.
Guadalajara, Jalisco 44280
MexicoSite 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
MexicoSite Not Available
Hospital Civil de Guadalajara Hospital 278, El retiro, Torre Piso 10, Infectología Ped.
Guadalajara Jalisco, 44280
MexicoSite Not Available
Hospital de Especialidades Ped Via España y Calle Zarak
Ciudad de Panama, 0801
PanamaSite Not Available
Hospital del Niño, Epidemiologia
Panama City, 0816-00383
PanamaSite Not Available
Chong Hua Hospital
Cebu City, 6000
PhilippinesSite Not Available
Western Visayas and Medical Center
Iloilo City, 5000
PhilippinesSite Not Available
Western Visayas and Medical Center
Jaro Iloilo City, 5000
PhilippinesSite Not Available
Manila Doctor's Hospital
Manila, 1000
PhilippinesSite Not Available
Manila Doctors' Hospital
Metro Manila, 1000
PhilippinesSite Not Available
Hospital Val d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital del Mar, Passeig Marítim 25-29
Barcelona, 8003
SpainSite 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
UkraineSite 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
UkraineSite Not Available
Vinnytsia Regional Children's Hospital
Vinnytsia, 21000
UkraineSite Not Available
Vinnytsa Regional Children's Hospital
Vynnytsia, 21000
UkraineSite Not Available
Zaporizhzhia Regional Children Clinical Hospital
Zaporizhzhia, 69063
UkraineSite Not Available
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa 52242
United StatesSite Not Available
Cook Children's Medical Center
Fort Worth, Texas 76104
United StatesSite Not Available
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