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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.

NCT02141516

Meningococcal Disease

COMPLETED PHASE3

National Bacterial Meningitis Study

NCT04664569

Meningitis Children, Only Pneumococcal Conjugate Vaccine +5 more

RECRUITING

Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®

NCT00269477

Meningitis Meningococcal Infection

COMPLETED PHASE2

Daptomycin in Pediatric Patients With Bacterial Meningitis

NCT01522105

Meningitis

TERMINATED PHASE1

Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents

NCT00297817

Meningococcal Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meningitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Meropenem

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Meropenem trihydrate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No