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Meningitis, Bacterial clinical trials

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NCT ID: NCT05146570 Recruiting - Implant Infection Clinical Trials

Early Diagnosis of Native and Device-associated Meningitis

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Device-associated meningitis is a severe complication after implantation of various central nervous system (CNS) devices such as ventriculoperitoneal (VP) and ventriculoatrial (VA) shunts, external ventricular drains (EVD), lumbar drains (ELD) and intrathecal pumps. In contrast to native meningitis, these infections are hard to diagnose both clinically and on the laboratory basis due to (i) atypical clinical manifestation, (ii) overlapping inflammation following surgery, and (iii) common culture negativity due to previous antibiotic therapy and slow growth of low-virulent pathogens. Also, device-associated infections are difficult to differentiate from aseptic shunt failure (dysfunction) or "chemical meningitis" caused by underlying neurosurgical condition that prompted the placement of the CNS device (e.g. intracranial hemorrhage). Both native and device-associated meningitis carry substantial morbidity and mortality. Rapid and reliable diagnosis of meningitis is critical for initiating and choosing optimal treatment and minimizing the brain damage. Since treatment is different in septic than aseptic meningitis, it is paramount to diagnose or exclude septic meningitis as soon as possible. Several new diagnostic methods, such as cerebrospinal fluid (CSF) procalcitonin, interleukin-6 and polymerase chain reaction (PCR) have been proposed for rapid diagnosis of meningitis. However, insufficient sensitivity and/or specificity, long time until test result, and complexity in handling or interpretation of results limit their use in clinical routine. In previous studies CSF D-lactate test showed good specificity and sensitivity in patients with native meningitis. This biomarker is pathogen-specific - in contrast to other currently used host-specific biomarkers (leukocyte count, L-lactate, procalcitonin). However, no study on effectiveness of D-lactate test for the diagnosis of device-associated meningitis has been performed. Successful management of device-associated meningitis depends upon appropriate control of the infectious complications. To deal with such complications, adequate assessment and prediction of the clinical course are needed. Another use of D-lactate test could be his role as prognostic factor of the clinical course of device-associated meningitis.

NCT ID: NCT04929925 Not yet recruiting - Clinical trials for CNS Infection in Children

The Role of Serum Procalcitonin in Diagnosis and Detection of Outcome of Acute Bacterial Meningitis in Childern

Start date: June 15, 2021
Phase:
Study type: Observational [Patient Registry]

Meningitis is one of the most common central nervous system (CNS) infections encountered in infants and children. The source of infection in meningitis can be bacterial, viral, fungal, or parasitic in origin . Bacterial meningitis is a paediatric emergency with high mortality and morbidity rate. Hence it must be diagnosed and treated promptly. But the similar clinical presentation often makes it difficult to differentiate bacterial and non-bacterial aetiologies in children .

NCT ID: NCT04771884 Recruiting - Clinical trials for Bacterial Meningitis

Population Pharmacokinetics of Commonly Used Antimicrobial Agents in Children of Bacterial Meningitis With Augmented Renal Clearance

Start date: October 1, 2020
Phase:
Study type: Observational

The investigator's purpose is to study the population pharmacokinetics of commonly used antimicrobial agents in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility.

NCT ID: NCT04664569 Recruiting - Children, Only Clinical Trials

National Bacterial Meningitis Study

Start date: January 1, 2001
Phase:
Study type: Observational

Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.

NCT ID: NCT04196192 Completed - Clinical trials for Urinary Tract Infections

Febrile Infants - Diagnostic Assessment and Outcome

FIDO
Start date: March 1, 2020
Phase:
Study type: Observational

The purpose of this study is to assess how clinicians apply guidance in the assessment of febrile infants presenting the the Emergency Department. The measurable outcomes are: Primary Objective Report the rates of serious and invasive bacterial infections in febrile infants Secondary Objectives Report on the predictive value of different clinical features for predicting bacterial infections. Report on the value of biomarkers for predicting serious and invasive bacterial infections. Assess the performance of clinical practice guidelines for the assessment of febrile infants.

NCT ID: NCT04135053 Recruiting - Clinical trials for Meningitis, Bacterial

A Controlled Study to Assess Safety, Colonisation and Immunogenicity of Reconstituted Lyophilised Neisseria Lactamica

Lac5-Nasal
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

This study is part of a series of projects to develop and test new vaccines for meningitis. Previously researchers have given nose drops containing N. lactamica to over 350 volunteers, and shown that many of them (35-60%) can become colonised with N. lactamica and become resistant to becoming colonised with N.meningitidis without causing any illness or disease. In the future the study team would like to find out how N.lactamica helps children resist N.meningitidis, and develop new vaccines that exploit that mechanism.

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: NCT03891758 Completed - Tetanus Clinical Trials

Confirmatory Study of BK1310 in Healthy Infants

Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.

NCT ID: NCT03633474 Completed - Clinical trials for Meningitis, Bacterial

Defining the Immune Response to Nasopharyngeal Colonisation by the Commensal Neisseria Lactamica

Lac-7
Start date: September 1, 2018
Phase: Early Phase 1
Study type: Interventional

Neisseria meningitidis is a 'bad bacteria' which lives harmlessly in the nose and throat of many young adults (a process called colonisation). However, it can occasionally cause serious disease including meningitis. Vaccines have proven effective in preventing disease associated with a number of strains of this bacterium, however some disease-causing strains are not covered by currently available vaccines. This research is focused on exploring new approaches to preventing colonisation and disease caused by this bacterium. Neisseria lactamica is a 'good bacteria' that colonises the nose and throat of young children. It does not cause disease in healthy people. In a previous study it has been demonstrated that the introduction of Neisseria lactamica into the noses of healthy adult volunteers resulted in a significant decrease in Neisseria meningitidis colonisation. However, it is not yet understood why this effect occurs. One theory is that the immune response the body mounts in response to colonisation with the 'good bacteria' cross-reacts with the 'bad bacteria' and in so doing eradicates the bad bacteria from the nose and throat. This study aims to outline the nature of the immune responses mounted in response to colonisation with the good bacteria, N. lactamica, after introducing it into the noses of healthy adult volunteers. In addition, the study aims to establish how the introduction of the good bacteria changes the other bacterial populations that live in the nose and throat.

NCT ID: NCT03630250 Completed - Clinical trials for Meningitis, Bacterial

Challenge of the Nasopharynx With Neisseria Lactamica Expressing the Meningococcal Protein Neisseria Adhesin A (NadA)

NadA-Lac4
Start date: October 18, 2018
Phase: Early Phase 1
Study type: Interventional

This study is part of a research programme that aims to improve ways of protecting people from serious illnesses such as meningitis and sepsis caused by a bacterium called Neisseria meningitidis (N. meningitidis), using a closely related but harmless bacterium called Neisseria lactamica (N. lactamica). Investigators have previously given nose drops containing N. lactamica to over 350 volunteers - this is known as inoculation. In these studies the investigators have shown that they can cause colonisation of many inoculated volunteers (35-60%) with N. lactamica. Colonisation is when bacteria survive on or in a person without causing any illness or disease. N. lactamica specifically colonises the nose and throat. Investigators have also shown that colonisation with N. lactamica results in an immune (antibody) response. In this study investigators will be using a genetically modified version of N. lactamica which contains a single gene from N. meningitides. It is anticipated that the presence of this gene will change the number of people who are colonised and how long people remain colonised for, as well as causing them to produce an immune response to N. meningitides. The purpose of this study are to prove that inoculation with this modified N. lactamica does not cause any symptoms or illness, and to analyse the immune response produced in healthy volunteers.