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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
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
HEATH, Paul
London, Cranmer Terrace, United Kingdom
Pharmacokinetics of Meropenem (plasma and CSF) in infants ≤ 90 days of age diagnosed with probable and confirmed bacterial meningitis.
Pharmacokinetic analyses (AUC) will be carried out on the infants who received at least one dose of meropenem after inclusion in NeoMero-2. The final model will be used for dosing simulations to give final dose recommendations.
Time frame: 3-4 days
Nature, frequency and numbers of all adverse events under meropenem.
Adverse events will also be summarised according to the need of a specific medical intervention or not. Analyses by time period will also be shown (from D0 to TOC visit and from TOC visit to follow-up).
Time frame: Up to 48 days
Percentage of patients with a favourable outcome defined at Test of Cure visit (TOC).
Patients with a favourable outcome defined at Test of Cure visit (TOC) 2 days after EOAT is met as an infant fulfilling the following criteria: Alive with clinical and bacteriological resolution of the abnormalities that defined BM at entry and no occurrence of any new clinical or laboratory abnormalities requiring a new course of antibiotic therapy and no modification of the initial meropenem therapy (for more than 24 hours).
Time frame: An expected average of 21 days
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