Study of cefiderocol or standard of care for paediatric patients withconfirmed or suspected Gram-negative bacterial infections receiving asingle dose and paediatric patents with confirmed or suspectedcomplicated urinary tract infections, hospital-acquired pneumonia (HAP) orventilator-associated pneumonia (VAP) receiving multiple doses to assessthe safety, tolerability and exposure of cefiderocol.
- Conditions
- Single dose: Pneumonia, cUTI, complicated intra-abdominal infections [cIAI], hospital acquired pneumonia [HAP]/ventilator-acquired pneumonia [VAP], and sepsis or bloodstream infections [BSI]).Multiple dose: cUTI, HAP/VAPMedDRA 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: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: PTClassification code 10003997Term: BacteraemiaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2019-002121-30-LT
- 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
- 85
1. Subject's parent(s) or legally authorized representative(s) (LAR)[s])
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 board/independent
ethics committee [IRBs/IECs] 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 for the multiple-dose
phase. Hospitalized subject is 3 months to < 12 years of age at the time
written informed consent/assent is obtained for the single-dose phase.
Premature babies will not be restricted, but the subject must have an
adjusted or postnatal age of 3 months.
4. Single-dose phase: Subject has a suspected or confirmed infection (including but not limited to cUTI, cIAI, pneumonia, HAP/VAP, and sepsis or BSI) that requires hospitalization for treatment with IV antibiotics.
Multiple-dose phase: Subject has a suspected or confirmed cUTI (with a positive urine dipstick test for pyuria and, when possible, microscopy
demonstrating = 105 colony forming units (CFU)/mL in a midstream urine specimen or = 5 x 104 CFU/mL in a clean catheter catch urine
specimen) or HAP, or VAP 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: 85
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 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 mL/min/1.73 m2
at Screening.
Multiple-dose phase: Subject 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. See Protocol Section 7.5.3.1.2 for eGFR calculations and
ranges.
6. Subject has end-stage renal disease (ESRD), is on hemodialysis (HD),
or receiving continuous venovenous hemofiltration (CVVH).
7. Subject has experienced 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 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.
15. Subject is receiving vasopressor therapy at screening.
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