Meropenem in meningitis in children up to 90 days of age

• Conditions: Bacterial meningitis in children up to 90 days of age; MedDRA version: 17.0Level: LLTClassification code 10004049Term: Bacterial meningitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-001521-25-EE
• Lead Sponsor: FONDAZIONE PENTA ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-19
• Last Update Posted: 2 March 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 (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

Study & Design

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