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

Phase 1

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

• Registration Number: EUCTR2022-001837-35-LT
• Lead Sponsor: Basilea Pharmaceutica International Ltd, Allschwil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-17
• Last Update Posted: 26 September 2023

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