Study to assess the safety, tolerability and exposure of cefiderocol in children with suspected or confirmed aerobic Gram-negative bacterial infections.
- Conditions
- 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: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: LLTClassification code 10076918Term: Hospital acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10065153Term: Ventilator associated pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10079983Term: Complicated intra-abdominal infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: PTClassification code 10003997Term: BacteraemiaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: PTClassification code 10053840Term: Bacterial sepsisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2019-002120-32-LV
- Lead Sponsor
- Shionogi B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 64
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 < 18 years of age at the time written informed consent/assent is obtained
4.Subject has a suspected or confirmed infection (including but not limited to cUTI, cIAI, pneumonia [including HAP/VAP], sepsis, or BSI) that requires hospitalization for treatment with IV antibiotics
5.If subject is a sexually active female of childbearing potential and has reached menarche or Tanner stage 3, subject 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 64
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 bed-side Schwartz equation [2009]) of < 60 mL/min/1.73 m2 at Screening
Multiple-dose phase: Subject has an eGFR (based on modified bed-side 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 is in refractory septic shock defined as persistent hypotension despite adequate fluid resuscitation or vasopressive therapy at Screening
8.Subject has severe neutropenia or is severely immunocompromised
9.Subject has multiorgan failure
10.Subjects with 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method