Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age With Probable and Confirmed Meningitis (NeoMero-2)
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Pharmacokinetics of Meropenem (plasma and CSF) in infants ≤ 90 days of age diagnosed with probable and confirmed bacterial meningitis. [ Time Frame: 3-4 days ] [ Designated as safety issue: Yes ]
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.
- Nature, frequency and numbers of all adverse events under meropenem. [ Time Frame: Up to 48 days ] [ Designated as safety issue: Yes ]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).
- Percentage of patients with a favourable outcome defined at Test of Cure visit (TOC). [ Time Frame: An expected average of 21 days ] [ Designated as safety issue: Yes ]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).
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
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
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
Other Name: Meropenem trihydrate
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
|London, Cranmer Terrace, United Kingdom, SW17 ORE|
|Contact: Tatiana Munera + 44 02087255382 firstname.lastname@example.org|
|Principal Investigator: Paul Heath|
|Principal Investigator:||Paul HEATH||Paediatric Infectious Diseases St Georges, University of London|
|Study Chair:||Jean-Pierre ABOULKER||Institut National de la Santé Et de la Recherche Médicale, France|