NCT01554124

Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age With Probable and Confirmed Meningitis

Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age (Inclusive) With Probable and Confirmed Meningitis: A European Multicenter Phase I-II Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: PENTA Foundation · Network
• Sex: All
• Age: 90 Days
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Meningitis

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-03-14
• Last updated: 2015-02-16

Locations

1 site across 1 country: United Kingdom