- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01554124
Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age With Probable and Confirmed Meningitis (NeoMero-2)
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 Overview
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
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Cranmer Terrace
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London, Cranmer Terrace, United Kingdom, SW17 ORE
- HEATH, Paul
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Meropenem
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
3-4 days
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Nature, frequency and numbers of all adverse events under meropenem.
Time Frame: Up to 48 days
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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An expected average of 21 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-001521-25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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