Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age With Probable and Confirmed Meningitis (NeoMero-2)

PENTA Foundation

Status and phase: Completed; Phase 2; Phase 1

Conditions: Meningitis

Treatments: Drug: Meropenem

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT01554124

2011-001521-25

Details and patient eligibility

About

This phase I-II multicenter international trial is designed to study the pharmacokinetics of meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis.

Full description

The primary objective will be to study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis.

The secondary objectives are :

• To describe the efficacy of meropenem on day 3, at end of allocated treatment (EOAT), at test of cure (TOC) and at follow up (FU).
• To evaluate survival at FU
• To evaluate further episodes of meningitis (relapse or new infection) occurring between TOC and FU visits
• To define the organisms causing neonatal meningitis
• To describe the antibacterial susceptibility of meningitis-causing organisms and to describe the clinical and microbiological response according to this
• To evaluate mucosal colonization by resistant organisms before and after treatment with meropenem
• To evaluate bacterial eradication
• To evaluate functional genetic parameters that may affect response to therapy

Enrollment: 51 patients

Sex: All

Ages: Under 90 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent form signed by the parents/carers

• Chronological age below 90 days inclusive

• The presence of:

  • clinical signs consistent with BM (hyperthermia 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.

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Meropenem

Experimental group

Description:

Infants will received Meropenem 40 mg/kg every 8 hours (every 12 hours in the youngest age group: \< 32 weeks GA and \< 2 weeks postnatal age). Treatment duration = 21 ± 7 days

Treatment:

Drug: Meropenem