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NCT Number: NCT01554124

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

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.

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Key information

Conditions

Meningitis Nervous System Diseases Neuroinflammatory Diseases

Age range

Up to 90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

HEATH, Paul

London, Cranmer Terrace, SW17 ORE, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meropenem

Drug

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 names: Meropenem trihydrate

Primary outcomes

  1. Pharmacokinetics of Meropenem (plasma and CSF) in infants ≤ 90 days of age diagnosed with probable and confirmed bacterial meningitis.

    Time frame: 3-4 days

    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.

  2. Nature, frequency and numbers of all adverse events under meropenem.

    Time frame: Up to 48 days

    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).

Secondary outcomes

  1. Percentage of patients with a favourable outcome defined at Test of Cure visit (TOC).

    Time frame: An expected average of 21 days

    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).

Sponsors and collaborators

Lead sponsor

PENTA Foundation

Network

Collaborators

  • Chiesi Farmaceutici S.p.A.

Registry information

Official study 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

Acronym: NeoMero-2

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 14, 2012
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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