Pharmacokinetics and safety of Meropenem in infants below 90 days of age (inclusive) with probable and confirmed meningitis: a European multicenter phase I- II trial

Phase 2

Completed

Conditions: bacterial meningitis
infection of the central nervous system
10004018
10007951

Registration Number: NL-OMON39472

Lead Sponsor: PENTA Foundation / Dept. of Pediatrics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Informed consent form signed by the parents/carers
- Chronological age below 90 days inclusive
- The presence of: clinical signs consistent with bacterial meningitis (clinical signs of meningitis are: fever or hypothermia or temperature instability PLUS 1 or more neurological findings e.g. 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics: The final model will be used for dosing simulations to give<br /><br>final dose recommendation.<br /><br>Safety of meropenem: The nature, frequency and numbers of all adverse events<br /><br>will be described.<br /><br>Safety and pharmacokinetic analyses will be carried out on the infants who<br /><br>received at least one dose of meropenem after inclusion in neomero 2.</p><br>

Secondary Outcome Measures