How well does meropenem treat meningitis in infants below and including 90 days of age

• Conditions: Proven or suspected bacterial meningitis in neonates and infants up to 90 days of age.; MedDRA version: 15.0Level: 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-GB
• Lead Sponsor: FONDAZIONE PENTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-21
• Last Update Posted: 4 August 2015

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 (fever 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.

Notes:
1. Where the initial results of the lumbar puncture do not support a diagnosis of meningitis e.g. where the cell count is < 20 cells/mm3, but the subsequent CSF culture (or PCR (see later)) is positive for a significant pathogen, then the infant will still be eligible for recruitment when these results become known.
2. Where the early lumbar puncture is deferred, for example, because the infant is clinically unstable, but the delayed lumbar puncture supports a diagnosis of meningitis (as above), then the infant will still be eligible for recruitment.
3. If the lumbar puncture is traumatic, the normal” ratio of 500 RBC: 1 WBC will be used to evaluate the CSF WCC result.

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified