ate-onset sepsis in term and pre-term neonates and infants up to 3 months of age

Phase 1

Conditions: MedDRA version: 20.1Level: LLTClassification code 10053598Term: Late onset neonatal sepsisSystem Organ Class: 100000004862
ate-onset sepsis (LOS) in term and pre-term neonates andinfants up to 3 months of age.
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2022-001837-35-PL

Lead Sponsor: Basilea Pharmaceutica International Ltd, Allschwil

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 15

Inclusion Criteria

1. Informed consent from parent(s) or other legally-acceptable representative (LAR) to participate in the study
2. Male or female, with a gestational age of = 24 weeks and a post-natal age ranging from = 3 days to = 3 months
3. Diagnosis of documented or presumed bacterial LOS requiring administration of systemic antibiotic treatment.
4. Sufficient vascular access to receive study drug and to allow blood sampling at a site separate from the study drug infusion line
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
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

Exclusion Criteria

1. Refractory septic shock not responding to 60 minutes of vasopressor treatment within 48 hours before enrollment
2. Proven ventilator-associated pneumonia
3. Proven central nervous system infection (e.g., meningitis, brain abscess)
4. Proven osteomyelitis, infective endocarditis, or necrotising enterocolitis
5. Impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula or other applicable formula) calculated to be less than 2/3 of normal for the applicable age group, OR urinary output < 0.5 mL/kg/h (measured over at least 8 hours), OR requirement for dialysis
6. Progressively fatal underlying disease, or life expectancy < 30 days
7. Use of systemic antibacterial therapy for longer than 72 hours within 7 days before start of study medication
8. Participation in another clinical study with an investigational product within 30 days of enrollment in the current study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterise the safety profile of ceftobiprole in term and pre-term neonates and infants<br>up to 3 months of age with LOS.;Secondary Objective: To assess in term and pre-term neonates and infants up to 3 months of age with LOS treated<br>with ceftobiprole:<br>- PK of ceftobiprole<br>- Clinical response<br>- All-cause mortality<br>- Microbiological response;Primary end point(s): The primary endpoint is safety and tolerability in the Safety population, as assessed by adverse events (AEs), serious adverse events (SAEs), deaths, and discontinuations due to AEs during treatment with ceftobiprole and at the end of treatment (EOT), test of cure (TOC), and last follow-up (LFU) visits, as well as clinical laboratory tests, vital signs, and physical examination findings.;Timepoint(s) of evaluation of this end point: At the EOT, TOC, and LFU visits, as well as clinical laboratory tests, vital signs, and physical examination findings.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pharmacokinetics<br>- Plasma levels of ceftobiprole, ceftobiprole medocaril, and the open-ring metabolite in the PK population<br>Efficacy<br>- Clinical cure rate at the EOT and TOC visits (ITT and CE populations)<br>- All-cause mortality through Day 28 (ITT population)<br>- Microbiological eradication or presumed eradication rate at the EOT and TOC visits (mITT and ME populations)<br>- Improved signs and symptoms of LOS at the Day 3, EOT, and TOC visits (ITT and CE populations);Timepoint(s) of evaluation of this end point: At Day 3, Day 28, EOT and TOC visit.

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