Pharmacokinetics and safety of meropenem in infants below 90 days ofage (inclusive) with probable and confirmed meningitis: a Europeanmulticentre phase I-II trial

Conditions: proven or suspected bacterial meningitis in neonates and infants up to90 days of age
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2011-001521-25-GR

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: 60
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