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

Information source: PENTA Foundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Meningitis

Intervention: Meropenem (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: PENTA Foundation

Official(s) and/or principal investigator(s):
Paul HEATH, Principal Investigator, Affiliation: Paediatric Infectious Diseases St Georges, University of London
Jean-Pierre ABOULKER, Study Chair, Affiliation: Institut National de la Santé Et de la Recherche Médicale, France

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

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

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

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

Eligibility

Minimum age: N/A. Maximum age: 90 Days. Gender(s): Both.

Criteria:

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

Locations and Contacts

HEATH, Paul, London, Cranmer Terrace SW17 ORE, United Kingdom
Additional Information

Site dedicated to the NeoMero studies

Starting date: February 2013
Last updated: February 12, 2015

Page last updated: August 23, 2015

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