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Meningitis clinical trials

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NCT ID: NCT06449066 Not yet recruiting - Clinical trials for Obstetrical Neuraxial Anaesthesia

Primary Immunodeficiencies and Obstetrical Neuraxial Anaesthesia

ANEU-DIP
Start date: June 2024
Phase:
Study type: Observational

The purpose of this study is to evaluate if neuraxial anesthesia (epidural or intradural anesthesia) used during childbirth is associated with more frequent infectious complications in patients with primary immunodeficiencies (PID).

NCT ID: NCT06446245 Not yet recruiting - Clinical trials for Tuberculosis, Meningeal

Adjunctive Doxycycline for Central Nervous System Tuberculosis

DIRECT
Start date: July 2024
Phase: Phase 2
Study type: Interventional

Although tuberculosis is now considered a treatable disease, central nervous system tuberculosis (CNS-TB) when managed with the current standard-of-care (SOC), still has mortality rates ranging from 30-50% even in tertiary hospital centers. At present, the SOC for the management of CNS-TB is anti-tuberculous therapy with adjunctive corticosteroids. In CNS-TB, the activity of pathogenic host matrix metalloproteinases (MMPs) is unopposed to tissue inhibitors of metalloproteinases (TIMPs), resulting in a matrix-degrading phenotype which may drive worse outcomes in CNS-TB. In a prior established CNS-TB murine model, the investigators have demonstrated that adjunctive MMP inhibition using doxycycline, a widely available and cheap drug, in addition to standard TB treatment, compared with standard TB treatment alone, improved murine survival (Manuscript in preparation). The investigators previously showed that in humans with pulmonary TB, doxycycline with anti-TB treatment is safe, accelerates the resolution of inflammation, and suppresses systemic and respiratory MMPs. Hence, the investigators are now ideally positioned to determine if adjunctive doxycycline in patients with CNS-TB can improve clinical outcomes. The investigators will perform a Phase 2 double-blind randomized-controlled trial (RCT) of adjunctive doxycycline versus placebo with standard TB treatment and steroids for 8 weeks, with the primary outcome of 8-week mortality or severe neurological deficits.

NCT ID: NCT06389513 Not yet recruiting - Epidemic Meningitis Clinical Trials

Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants

Start date: June 2024
Phase: Phase 4
Study type: Interventional

This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age.

NCT ID: NCT06337071 Not yet recruiting - Clinical trials for Meningococcal Meningitis

A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

Start date: March 20, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination.

NCT ID: NCT06226714 Not yet recruiting - Clinical trials for Meningococcal Meningitis

A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds

Start date: March 2024
Phase: Phase 3
Study type: Interventional

This is a randomized, observer-blind, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups.

NCT ID: NCT06113198 Not yet recruiting - Clinical trials for Meningitis, Meningococcal

A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age

Start date: November 15, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the safety and immune responses of rMenB+OMV NZ vaccine when administered to healthy infants from 2 months in the Republic of Korea according to a 2-dose primary schedule and 1 booster dose.

NCT ID: NCT06075732 Not yet recruiting - COVID-19 Clinical Trials

ACTIVATE in Public Housing

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This multilevel, multidisciplinary, theoretically based, culturally sensitive, community-engaged intervention sets out to mitigate uptake barriers and non-adherence to vaccination schedules as recommended by the CDC and increase influenza, meningitis, pneumonia, VZV, and COVID-19 vaccine rates among under-resourced African American and Latino public housing residents in South Los Angeles.

NCT ID: NCT05917340 Not yet recruiting - Clinical trials for Tuberculous Meningitis

Intensified Short Course Regimen for TBM in Adults

INSHORT
Start date: March 2024
Phase: Phase 3
Study type: Interventional

Tuberculous meningitis (TBM) is the most lethal form of extra pulmonary tuberculosis. This devastating disease kills almost a third of its sufferers and disables a significant proportion of the survivors. TBM poses one of the most difficult diagnostic and therapeutic challenges in modern clinical practice. High-quality robust clinical trials have made a considerable contribution to the treatment of pulmonary tuberculosis in the last four decades. However, evidence from such clinical trials is lacking in TBM and the treatment remains uncertain. There is a significant variation in the choice, dose and duration of drugs between countries, institutions and clinicians. Investigators propose a multi-centric open-label clinical trial to assess the efficacy of short-course anti-TB drugs with high dose rifampicin, and moxifloxacin along with conventional anti-TB drugs and adjuvant therapy with aspirin and corticosteroids. Controls will receive standard treatment as per national guidelines for TBM. The investigators also aim to assess the safety and tolerability of high-dose Rifampicin and Moxifloxacin and the Pharmacodynamics and Pharmacokinetics parameters of ATT (Rifampicin, INH, Moxifloxacin and Pyrazinamide) in CSF between the two groups

NCT ID: NCT05777499 Not yet recruiting - Stroke Clinical Trials

MUSic Therapy In Complex Specialist Neurorehabilitation

MUSICS
Start date: March 2023
Phase: N/A
Study type: Interventional

Aim: Investigate whether patients undergoing specialist rehabilitation after complex neurological injury show different functional outcomes if music therapy is included in their rehabilitation program compared to usual care. Background: Patients with complex needs following a brain, spinal cord, and/or peripheral nerve injury often require a period of specialist neurorehabilitation. This involves multiple therapy disciplines, led by a Consultant in Rehabilitation Medicine, Neurology, or Neuropsychiatry. Although music therapy is suggested to enhance neuroplasticity and recovery in patients with brain injury, it is not routinely commissioned in clinical care due to a lack of supportive evidence. Hypothesis: Patients undergoing music therapy in addition to complex specialist rehabilitation show better functional outcomes compared to usual care. Number of participants: 75, aged 16-80 years. Methods: Patients undergo baseline assessments and are randomised to MUSIC or CONTROL Therapy. Both arms receive 1-3 additional therapy sessions per week, matched for duration and number, total 15 hours. After approximately 10-weeks intervention, assessments are repeated. All participants then have access to music therapy until they are discharged from Neurorehabilitation Unit (NRU), with additional qualitative data collection using semi-structured interviews, field notes, staff reports, staff stress surveys, and broader ecological observations. Duration for Participants: From consent to discharge from NRU. Primary Outcome: Change in Functional Independence Measure+Functional Assessment Measure (FIM+FAM), Northwick Park Dependency Scale (NWPDS), and Barthel Activities of Daily Living pre and post 15 hours intervention. Secondary Outcome: Change in quality of life (Flourishing Scale), psychological distress (Hospital Anxiety and Depression Scale, Depression Intensity Scale Circles), social interaction (Sickness Impact Profile Social Interaction Subscale), well-being (WHO Well-Being Index), and communication (Communication Outcomes After Stroke Scale), pre and post 15 hours intervention. Mean difference in well-being (WHO Well-Being Index) throughout the intervention period between music therapy and control therapy groups. Mean difference in post-intervention pain and mood visual analogue scores between music therapy and control therapy groups.

NCT ID: NCT05685641 Not yet recruiting - Clinical trials for Acquired Immunodeficiency Syndrome

Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City

PREVALIOCDMX
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

In Mexico City, the main cause of mortality among people living with HIV (PLHIV) continues to be opportunistic infections (OIs). Early detection of OIs allows their timely treatment and improves their prognosis. The use of rapid diagnostic tests (RDT) based on antigens of the most frequent causative agents of OIs allows adequate screening of these patients and facilitates decision making at the point of care. Unfortunately, these studies are not widely available in the different PLHIV care centers in the CDMX. We will conduct an open-label, non-inferiority uncontrolled clinical trial to investigate the diagnostic performance of urinary lipoarabinomannan, urinary Histoplasma antigen and serum Cryptococcus antigen in patients presenting for care with advanced HIV in CDMX, supported by rapid cluster of differentiation 4 (CD4) testing with lateral flow technology. Four referral hospitals will participate over 12 months. All patients with diagnosed HIV disease and suspected advanced disease presenting for care at participating centers will be included in the study. An inventory of approximately 1000 RDT will be obtained and distributed among the participating sites. A study coordinator will be hired and will visit each site once a week to collect the study variables and follow up on the included patients. The primary outcome of the study will be the percentage of patients with advanced disease who present with diagnoses made by RDT compared to historical controls of patients diagnosed with OI in 2022 at participating centers by conventional methods. Secondary outcomes will be time to initiation of antiretroviral therapy (ART), time to initiation of OI treatment, and 30-day mortality after HIV diagnosis.