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Meningitis clinical trials

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NCT ID: NCT04009551 Recruiting - Neonatal Meningitis Clinical Trials

Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study

NEO-MENINGITIS
Start date: June 1, 2019
Phase:
Study type: Observational

Meningitis, defined as inflammation of the meninges caused by different pathogens, is a serious infection associated with high morbidity and mortality. It occurs more commonly in the neonatal period than in any other age group. Neonatal meningitis is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality. In this study, we aimed to evaluate epidemiology, treatment and prognosis of neonatal meningitis in a large-scale retrospective multicenter cohort study. The main objectives of this study were to assess the incidence, temporal trend, risk factors, causative organisms, and short term outcomes of neonatal meningitis in a large national cohort of newborn infants admitted to Turkey NICUs.

NCT ID: NCT03983616 Recruiting - Clinical trials for Pneumococcal Infections

Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)

SIIP
Start date: April 2014
Phase:
Study type: Observational

Given the frequency and severity of invasive pneumococcal infections and questions about the place of VPC-13 in the prevention of pneumococcal infections in adults based on the presence of risk factors, current laboratory surveillance should be supplemented with data on the clinical features of adult invasive pneumococcal infections (IPI) cases. In particular it is necessary to collect for these cases, the clinical forms, the severity and the existence of risk factors and to make the link between these characteristics and those strains of pneumococci responsible for the IPI in particular, their serotype. The follow-up of the evolution of the cases according to the presence of risk factors, their clinical form and their serotype coverage (vaccine strain or not) must to guide recommendations for adult VPC-13 and to monitor the effects of VPC-13 vaccination recommendations. These effects are indirect, linked to the effect of vaccination of children with VPC-13 since 2010, which modifies the serotypes responsible for infections in vaccinated and unvaccinated patients, and the direct effects of possible use of the conjugate vaccine in adults (according to the recommendations that will be given by the Vaccination Technical Committee of the High Council of Public Health). The project is based on the existing network of 23 Regional Pneumococcal Observatories (ORP) located in metropolitan France and the network of infectious diseases by completing the microbiological collection of strains of pneumococci isolated from invasive infections in adults by a clinical collection in hospitals or voluntary clinics where the laboratory participates in the ORP. Given the establishment in 2012 of an adult bacterial meningitis observatory, to which the ORP are associated, this project does not include the surveillance of pneumococcal meningitis in adults.

NCT ID: NCT03967210 Completed - Meningitis Clinical Trials

Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis

KlebsieLCR
Start date: July 5, 2019
Phase:
Study type: Observational

Klebsiella pneumoniae is implicated in the occurrence of severe pneumonia. Most Klebsiella pneumoniae infections are associated with care and occur in patients with compromised immune defenses. More recently, cases of hepatic abscess and acute community meningitis related to strains of Klebsiella pneumoniae have been reported. The mortality of these infections is important, most often due to a delayed diagnosis. The poor prognostic factors reported in the literature for very low numbers are: advanced age, coma, septic shock, glyceryachia <10mg / dL and proteinuria> 750 mg / dL. In addition, no study has specifically focused on the factors of occurrence and factors associated with Klebsiella sp. Indeed, meningitis related to Klebsiella pneumoniae seems to be a rare but probably underestimated event whose risk factors, clinical presentation, microbiological are little known and the treatment modalities of this severe infection are not codified.

NCT ID: NCT03964012 Completed - Clinical trials for Meningococcal Meningitis

Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)

Start date: August 20, 2019
Phase: Phase 3
Study type: Interventional

This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra. A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years & 2-10 years (400 NmCV-5 recipients & 200 Menactra recipients in each age strata). Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA).

NCT ID: NCT03953638 Recruiting - Clinical trials for Next Generation Sequencing

Application of Next Generation Sequencing Technique in Pediatric Bacterial Meningitis

Start date: February 1, 2018
Phase:
Study type: Observational [Patient Registry]

Pathogen identification is of paramount importance for bacterial meningitis. At present, the pathogen of bacterial meningitis is still mainly based on Gram stain and bacterial culture. However, cerebrospinal fluid (CSF) culture can be negative in children who receive antibiotic treatment prior to CSF examination.Because of the limitations of clinical laboratory testing, more than half of the central nervous system infection cases cannot be clearly diagnosed. The emergence of powerful next-generation sequencing (NGS) technology have enabled unbiased sequencing of biological samples due to its rapid turnaround time. Previous reports highlight the feasibility of applying NGS of CSF as a diagnostic method for central nervous system (CNS) infection. However, the majority of reports are comprised of single case reports and few studies have been reported in the application of NGS for pathogen detection from CSF samples of bacterial meningitis patients, especially in pediatric populations. In this study, we would like to use the NGS technology to detect directly from the CSF samples of children with bacterial meningitis and evaluate the feasibility and significance of the NGS technique on the pathogenic identification of bacterial meningitis.

NCT ID: NCT03945448 Recruiting - Clinical trials for Cryptococcal Meningitis

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

ACACIA
Start date: June 20, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This will be a randomized controlled trial of asymptomatic (Cryptococcal Antigen test)CrAg positive persons in Uganda. Patients will be randomized to receive preemptive treatment with 1 dose of liposomal amphotericin (10mg/kg) in addition to standard of care fluconazole therapy. How the enhanced antifungal therapy prevents progression to meningitis in the first 24-weeks and overall survival in those who receive the intervention compared with participants receiving fluconazole per World Health Organisation (WHO) and national standard of care therapy will be evaluated.

NCT ID: NCT03927313 Completed - HIV-1-infection Clinical Trials

Linezolid, Aspirin and Enhanced Dose Rifampicin in HIV-TBM

LASER-TBM
Start date: June 12, 2019
Phase: Phase 2
Study type: Interventional

LASER-TBM is a parallel group, randomized, multi-arm phase IIa trial evaluating the safety of increased dose rifampicin (RIF) plus linezolid (LZD), with or without aspirin (ASA), for the treatment of HIV-infected adults with tuberculous meningitis (TBM). The study will recruit 100 HIV-infected adults with TBM across four sites in South Africa. The primary endpoint is the occurrence of solicited treatment-related adverse events. Secondary endpoints include death and disability (including neurocognitive impairment), radiological outcomes, and the occurrence of immune reconstitution inflammatory syndrome (IRIS). A nested pharmacokinetic (PK) substudy aims to: 1. Describe the plasma and cerebrospinal fluid (CSF) PK of LZD and high dose RIF. 2. Evaluate the relationship between drug exposures, toxicity and efficacy. 3. Compare exposures between intravenous and oral RIF administration. 4. Investigate the impact of high dose RIF on LZD and dolutegravir (DTG).

NCT ID: NCT03900091 Completed - Meningitis Clinical Trials

Paediatric Infections Point-Of-Care

PI-POC
Start date: April 1, 2019
Phase:
Study type: Observational

This study aims to identify the aetiology of childhood meningitis in Southwestern Uganda and develop and evaluate new methods for point-of-care diagnosis of childhood meningitis in a low-income setting. A prospective observational study including 600 children aged 0-12 years will be conducted during 1 year in Mbarara, Uganda. We estimate to recruit about 300 children with suspected meningitis (cases), and 300 with non-severe infection age-matched as controls.

NCT ID: NCT03898635 Recruiting - Clinical trials for Tuberculous Meningitis

Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis

Start date: January 1, 2018
Phase:
Study type: Observational

Tuberculous meningitis (TBM) is the most serious form of Mycobacterium tuberculosis infection, causing mortality and disability in more than half of the patients. Current standard treatment for TBM is based on those developed to treat pulmonary tuberculosis, which does not take into account the differential ability of anti-tuberculosis drugs to penetrate the brain. With both good central nervous system penetrance and anti-tuberculosis efficacy that have been demonstrated in drug-resistant tuberculosis, linezolid may be a promising antimicrobial in TBM treatment. The purpose of this study is to evaluate the effectiveness of linezolid in the treatment of TBM.

NCT ID: NCT03895281 Not yet recruiting - Clinical trials for Meningitis/Encephalitis

Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel

Start date: April 1, 2019
Phase:
Study type: Observational

The FilmArray Meningitis/Encephalitis (ME) Panel (hereinafter referred to as FilmArray ME Panel) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.