Meningitis Clinical Trial
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
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03445416 -
Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men
|
N/A | |
| Completed |
NCT02526394 -
Pertussis and Meningitis C Concomitant Vaccination in Adolescents
|
Phase 4 | |
| Completed |
NCT01442675 -
Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine
|
Phase 2 | |
| Completed |
NCT00539032 -
Immunology and Safety of Menactra® in Children in Saudi Arabia
|
Phase 3 | |
| Terminated |
NCT00428051 -
Colombia Epidemiologic Surveillance Study
|
N/A | |
| Recruiting |
NCT05496673 -
Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda
|
N/A | |
| Completed |
NCT02003495 -
Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine
|
Phase 3 | |
| Recruiting |
NCT00901602 -
Lebanese Interhospital Pneumococcal Surveillance Program
|
||
| Completed |
NCT00850603 -
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
|
Phase 4 | |
| Completed |
NCT02591290 -
Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects
|
Phase 4 | |
| Completed |
NCT03112031 -
Treatment With Tamoxifen in Cryptococcal Meningitis
|
Phase 2 | |
| Completed |
NCT02881957 -
Hypovitaminosis D in Neurocritical Patients
|
Phase 2/Phase 3 | |
| Completed |
NCT06334796 -
Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology
|
Early Phase 1 | |
| Completed |
NCT03378258 -
Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.
|
||
| Recruiting |
NCT05637645 -
Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section
|
N/A | |
| Completed |
NCT02841254 -
Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies
|
N/A | |
| Completed |
NCT02003313 -
Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine
|
Phase 3 | |
| Recruiting |
NCT01619462 -
Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children
|
Phase 3 | |
| Completed |
NCT01239043 -
Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
|
Phase 2 | |
| Completed |
NCT00495690 -
Impact of Daily Zinc Supplementation to Infants Born With Low Birth Weight on Death and Severe Disease
|
Phase 3 |