Meropenem for the treatment of serious bacterial infections in neonates and young infants
- Conditions
- proven or suspected bacterial meningitis in neonates and infants up to90 days of ageMedDRA version: 14.1Level: PTClassification code 10058780Term: Meningitis neonatalSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2011-001521-25-LT
- Lead Sponsor
- PENTA Foundation Onlus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method