Including but not limited to complicated urinary tract infection [cUTI], complicated intra-abdominal infection [cIAI], hospital-acquired pneumonia [HAP]/ventilator-acquired pneumonia [VAP], and sepsis or bloodstream infections [BSI] MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: LLT Classification code 10076918 Term: Hospital acquired pneumonia System Organ Cla
Conditions
Interventions
Product Code: S-649266
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: NA
Other descriptive name: S-649266
Concentration unit: g gram(s)
Concentration type: equal
Concentrat
Sponsors
Shionogi B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject’s parent(s) or legally authorized representative (LAR) provides written informed consent in accordance with regional and country-specific laws and regulations 2. Subject provides written informed assent, when feasible (age of assent to be determined by institutional review boards/independent ethics committees [IRB's/IEC's] or be consistent with local legal requirements) 3. Hospitalized subject is 3 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has a documented history of any hypersensitivity or allergic reaction to any ß-lactam antibiotic (Note: for ß-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment) 2. Multiple-dose only: Subject has an infection caused only by a confirmed Gram-positive pathogen 3. Subject has a suspected or confirmed central nervous system (CNS) infection (eg, meningitis, brain abscess, shunt infection) or osteomyelitis (which would require prolonged antibiotic therapy) 4. Subject has cystic fibrosis 5. Single-dose phase: Subject has moderate or severe renal impairment based on estimated glomerular filtration rate (eGFR) (based on modified Bedside Schwartz equation [2009]) of < 60 mL/min/1.73 m2 at Screening Multiple-dose phase: Subject has an eGFR (based on modified Bedside Schwartz equation [2009]) of < 15 mL/min/1.73 m2 at Screening 6. Subject has end-stage renal disease (ESRD), is on hemodialysis (HD), or receiving continuous venovenous hemofiltration (CVVH) 7. Subject has experienced septic shock in the prior month or is in shock at the time of Screening 8. Subject has severe neutropenia or is severely immunocompromised 9. Subject has multiorgan failure 10. Subjects has a life expectancy of < 30 days due to severity of a concurrent illness 11. Subject is a female who has a positive pregnancy test at Screening 12. Subject is a female who is breastfeeding 13. Subject has received any other investigational medicinal product (IMP) within 30 days 14. Subject has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data including acute trauma to the pelvis or urinary tract 15. Subject is receiving vasopressor therapy at Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric subjects 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 subjects 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 subjects 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 subjects 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections ;Secondary Objective: • Multiple-dose phase only: Whenever cefiderocol is admistered alone, to assess the clinical response at the Posttreatment visit (7 [±?4] days following End of Treatment [EOT]) and at the End-of-study (EOS) visit, AND to assess the microbiological response at the Posttreatment visit (7 [±?4] days) following EOT and EOS (if available).;Primary end point(s): Safety, tolerability and pharmacokinetics in patients treated with single dose or multiple dose.;Timepoint(s) of evaluation of this end point: safety; prior to, during, and after administration of study drug Pharmacokinetic; single dose - after dosing multiple dose - after the 6th to 12th dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: Multiple dose phase - end of trial (EoT) and post treatment (7 days after EoT +/- 4 days) | — |
Countries
Belgium, Georgia, Hungary, Latvia, Russian Federation, Thailand, Ukraine
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd
Outcome results
None listed