Pharmacokinetics and safety of meropenem in the treatment of meningitis in neonates and young infants

Conditions: proven or suspected bacterial meningitis in neonates and infants up to 90 days of age
MedDRA version: 14.1Level: LLTClassification code 10004049Term: Bacterial meningitisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2011-001521-25-NL

Lead Sponsor: PENTA Foundation (Fondazione Penta Onlus)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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