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

NCT01554124 | Completed Phase 1 DMC

• 1 other identifier: 2011-001521-25
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Meningitis

Keywords

Meningitis; Neonates; Meropenem

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Up to 48 days

Secondary Outcomes (1)

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

  An expected average of 21 days

Study Arms (1)

Meropenem

EXPERIMENTAL

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

Drug: Meropenem

Interventions

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

Also known as: Meropenem trihydrate

Meropenem

Eligibility Criteria

• Age: Up to 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PENTA Foundation: lead
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (1)

HEATH, Paul

London, Cranmer Terrace, SW17 ORE, United Kingdom

Location

Related Links

• Site dedicated to the NeoMero studies

MeSH Terms

Conditions

Meningitis

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Paul HEATH

  Paediatric Infectious Diseases St Georges, University of London

  PRINCIPAL INVESTIGATOR

• Jean-Pierre ABOULKER

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 14, 2012
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 16, 2015

Record last verified: 2015-02

Locations

GB (1)