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Clinical Trials/EUCTR2022-001837-35-DE
EUCTR2022-001837-35-DE
Active, not recruiting
Phase 1

A multicenter, open-label, single-arm, multiple-dose study to evaluate the safety,pharmacokinetics, and efficacy of ceftobiprole medocaril in term and pre-termneonates and infants up to 3 months of age with late-onset sepsis

Basilea Pharmaceutica International Ltd, Allschwil0 sites8 target enrollmentDecember 8, 2022
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DrugsZevtera®

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Basilea Pharmaceutica International Ltd, Allschwil
Enrollment
8
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 8, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Basilea Pharmaceutica International Ltd, Allschwil

Eligibility Criteria

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: 8
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.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
  • •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

Outcomes

Primary Outcomes

Not specified

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