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Meningitis clinical trials

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NCT ID: NCT04532463 Completed - Clinical trials for Cryptococcal Meningitis

Clinical Effectiveness and Safety of Amphotericin B With Flucytosine-Fluconazole Therapy for Cryptococcal Meningitis

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

To study the clinical effectiveness and safety of amphotericin B with flucytosine-fluconazole therapy for cryptococcal meningitis in patients with HIV infection.

NCT ID: NCT04450498 Completed - Clinical trials for Neisseria Meningitides Meningitis

A Study to Demonstrate Non-inferior Immunogenicity of Yuxi Walvax MPV ACYW® Vaccine in Healthy Subjects Aged 2-10 Years

Start date: December 23, 2020
Phase: Phase 4
Study type: Interventional

This is a phase IV, single-center, observer-blind, randomized, controlled vaccine trial in 2 to 10 years old healthy subjects. Each participant will receive a single intramuscular injection of one of the two vaccines either MPV ACYW® vaccine or Menactra ® vaccine according to the vaccine group assignment and will be followed up for one month for immunogenicity evaluation and for 6 months for safety evaluation. Statistical Hypothesis: H0: Seroconversion rate of test group is inferior to that of control group HA: Seroconversion rate of test group is non-inferior to that of control group Sample size calculation: the sample size was calculated based on non-inferiority test with alpha level of 0.025 and 80% power, assuming seroconversion rate in control group was 95% with non-inferiority margin at 10%. The sample size required for the study is 124 per arm. After adjusting for 5% drop-out, the final sample size required is 130 per arm.

NCT ID: NCT04371003 Withdrawn - Oxidative Stress Clinical Trials

Prospective Investigation of Oxidative Stress in West Nile Virus Infection

PROWENI
Start date: September 1, 2020
Phase:
Study type: Observational

The investigator hypothesizes that oxidative stress responses to West Nile virus infection in the central nervous system determine the severity of infection and the long-term neurological, neuropsychological and functional sequelae of West Nile Neuroinvasive Disease.

NCT ID: NCT04325685 Completed - Clinical trials for Acute Respiratory Distress Syndrome

The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia

SGDC-VAP
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. As known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. The research team is considering that oropharyngeal decontamination with bacteriophages can prevent the developing of the ventilator - associated pneumoniae. There will be three groups in this investigation: placebo, antiseptic drug (Octenisept) and bacteriophage (Sexthaphag).

NCT ID: NCT04308928 Recruiting - Clinical trials for Tuberculous Meningitis

Evaluation of New Biomarker-based Approaches for Improving the Diagnosis of Childhood Tuberculous Meningitis

TBMBIOMARKER
Start date: April 1, 2020
Phase:
Study type: Observational

The rapid diagnosis of tuberculosis (TB) in children remains a serious challenge owing to limitations in the existing diagnostic tests. TB meningitis (TBM), an extrapulmonary form of TB, is the most severe manifestation of paediatric TB. TBM results in high morbidity and mortality in children, despite the availability of chemotherapy, mainly due to diagnostic delay. Most tests required for proper TBM diagnosis including analysis of cerebrospinal fluid (CSF) and brain imaging are not available in resource-limited settings e.g., in most of Africa including South Africa. New tests for TBM are urgently needed. The main goal of this proposal is to develop a point-of-care (POC) diagnostic test for TBM, based on CSF and bloodbiomarkers. Aim 1: Evaluate the diagnostic potentials of 51 host inflammatory biomarkers that the investigators recently identified in CSF and blood samples from children with suspected meningitis in a repository of 100 stored CSF and serum samples using a multiplex platform. After statistical analysis including multi-marker modelling by linear discriminant analysis, random forest, and other modelling techniques, the investigators will select the best combination of up to four biomarkers for incorporation into the prototype diagnostic test (Aim 2). Aim 2: Incorporate the best performing CSF and serum biomarkers into a novel, patented biosensor-based POC diagnostic test. The investigators will develop a multi-biomarker prototype test for detecting up to 4 biomarkers in serum or CSF. Aim 3: Evaluate the newly developed POC test on 300 children prospectively. This will be done at the Tygerberg Academic Hospital. The diagnostic yield of the POC test will be compared to the routine diagnostic tests.

NCT ID: NCT04296292 Completed - HIV Clinical Trials

The Lived Experience of Participants in an African Randomised Trial

LEOPARD
Start date: February 5, 2020
Phase:
Study type: Observational

There has been no previous qualitative study conducted in a low-income setting which has aimed to explore the experience of individuals who enrol into a clinical trial for the management of a life-threatening illness. The investigators plan to collect data from trial participants, their next-of-kin, and researchers working on a multi-site randomised controlled trial for the treatment of HIV-associated cryptococcal meningitis.

NCT ID: NCT04275284 Completed - Pneumonia Clinical Trials

Persistence of Immunogenicity Following Reduced PCV Dosing Schedules in South African Children

PCV1+1_FU
Start date: February 14, 2020
Phase:
Study type: Observational

This study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent Pneumococcal Conjugate Vaccine (PCV10, PCV13). This is the follow-up of a randomized controlled trial in which children received a single priming dose of PCV10 or PCV13 (at 6 or 14 weeks of age) followed by booster dose at 9 months of age (1+1 schedule), compared to a 2+1 PCV schedule (6, 14 weeks of age and 9 months of age).

NCT ID: NCT04224311 Active, not recruiting - Clinical trials for Preventive Immunization; Meningitis

Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors

PLAT
Start date: March 12, 2020
Phase: Phase 4
Study type: Interventional

In this study, the investigators will evaluate the immunogenicity of a quadrivalent conjugate meningococcal vaccine in healthy, plateletpheresis donors.

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: NCT04190303 Active, not recruiting - Meningitis Clinical Trials

BIGlobal Intervention Study: Improving Diagnosis and Management of Suspected Brain Infections Globally

Start date: February 17, 2021
Phase:
Study type: Observational

Background: Patients with suspected brain infections pose major challenges to low and middle income countries, including their disproportionately high burden, diverse causes with inadequate surveillance, requirement for invasive and expensive tests, and the difficulty of management without a clear diagnosis. This is all compounded by resource and system constraints. Few studies have attempted to improve the care of these people in resource-limited settings. Aim: This study sets out to improve the diagnosis and early management of people with suspected acute (<28 days of symptoms) brain infections in low and middle income countries, using a coordinated thematic approach. Outcomes: The primary outcome will be proportion of people with suspected acute brain infection receiving a diagnosis. Secondary outcomes will include mortality, length of stay in hospital, quality of life, degree of disability, and proportion having a lumbar puncture test. Participants: Children and adults with features consistent with an acute brain infection, including meningitis and encephalitis, will be recruited at a variety of hospitals in Brazil, India and Malawi. Study procedures: An assessment of current practice and capabilities at each hospital, including patient and sample journey observations and interviews with healthcare staff, will identify barriers to optimal care. Using this, a sustainable pragmatic multi-component intervention will be produced, with components modifiable to each hospital's needs. Outcomes will be reassessed post-intervention.