Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age With Probable and Confirmed Meningitis

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I-II multicenter international trial is designed to study the pharmacokinetics of meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PENTA Foundation
• Collaborator: Chiesi Farmaceutici S.p.A.
• Treatments: Meropenem; Thienamycins

Criteria

Inclusion Criteria:

• Informed consent form signed by the parents/carers

• Chronological age below 90 days inclusive

• The presence of:

• clinical signs consistent with BM (hyperthermia or hypothermia or temperature instability PLUS 1 or more neurological findings among coma, seizures, neck stiffness, apnoea, bulging fontanelle),

• OR CSF pleocytosis (≥ 20 cells/mm3)

• OR a positive Gram stain of CSF.

Exclusion Criteria:

• Presence of a CSF device

• Proven viral or fungal meningitis

• Severe congenital malformations if the infant is not to expect to survive for more than 3 months

• Other situations where the treating physician considers a different empiric antibiotic regimen necessary

• Known intolerance or contraindication to the study medication

• Participation in any other clinical study of an investigational medicinal product

• Renal failure and requirement of haemofiltration or peritoneal dialysis

• Meningitis with an organism known to be resistant to meropenem