View clinical trials related to Tuberculosis.
Filter by:The clinical trial aimes to evaluate multiple large language models in respiratory disease consultations by comparing their performance to that of human doctors across three major medical consultation scenarios. The main question aims to answer are: - How do large language models perform in comparison to human doctors in diagnosing and consulting on respiratory diseases across various clinical scenarios? In three clinical scenarios including the online query section, the disease diagnosis section and the medical explanation section, research assistants or volunteers will be asked to cross-question all LLMs or real doctors using predefined online questions and their own issues. After each questioning session, a short washout period is implemented to eliminate potential biases.
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.
PRISM-TB is an international, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, noninferiority Phase 3 clinical trial for fluoroquinolone-susceptible multidrug-resistant/rifampin-resistant pulmonary tuberculosis (FQ-S MDR/RR-TB). The trial objective is to evaluate whether stratified medicine treatment strategies for FQ-S MDR/RR-TB, defined by a pre-specified risk stratification algorithm, have noninferior efficacy to a one-size-fits-all control regimen (the local standard-of-care [SOC] regimen consistent with preferred regimen(s) in international guidelines), as measured by TB-related unfavorable outcomes at Week 73.
Tuberculosis (TB) is one of the major global health threats and is the second leading infectious cause of death after COVID-19 in 2022. Extrapulmonary TB (EPTB), amongst which tuberculous pleuritis (TBP) is one of the most common subtypes, poses additional obstacles to global TB control due to its difficulty in diagnosis. The diagnosis of TBP is challenging. The ideal way of confirming TBP is by direct detection of TB bacteria or its specific component in the pleural space. However, the performance of available diagnostic tests is far from satisfactory, and no single test can achieve multiple diagnostic goals simultaneously, including high detection sensitivity, high specificity to exclude other diseases, low invasiveness and detection of drug resistance. The inability to diagnose TBP early leads to unnecessary invasive pleural procedures and delayed curative treatment. There is a pressing need for a better diagnostic test to diagnose TBP confidently. When TB bacteria die or break down, the DNA materials shed into the pleural space, forming Mycobacterium tuberculosis cell-free DNA (MTB cfDNA), which may aid in diagnosing TBP. However, only limited literature explored this aspect, and the sensitivity rates reported were still suboptimal due to the scarcity of DNA materials in the pleural fluid. Based on a small patient cohort, our group has recently developed a new laboratory assay measuring MTB cfDNA to overcome this problem, with a superior diagnostic performance to conventional tests. This assay can potentially capture the genes harbouring drug resistance towards anti-TB medications. There are three aims in this research proposal. First, the diagnostic accuracy of the new MTB cfDNA assay in diagnosing TBP will be determined using a large cohort containing pleural fluid samples of various causes from countries with different TB burdens. Second, the clinical and laboratory factors determining the pleural fluid MTB cfDNA level will be identified. Third, the ability of the assay to capture different anti-TB drug-resistance genes will be explored. This new diagnostic method will significantly enhance the pickup rate of TBP, benefit patients with less invasive procedures, shorter hospital stays and timely treatment.
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 & Day 180 after vaccinating all subjects.
As estimated by the WHO 10.6 million new Tuberculosis (TB) cases were identified in 2022- while more than three million went undetected and untreated. The low detection rate illustrates the failure to recognise and diagnose TB in the current cascade of healthcare and is a major obstacle to effective TB control programs. This multi-centre cluster-randomised clinical trial will evaluate the effect (i.e., diagnostic yield) of improving the point-of-care diagnostics already in place in most primary health-care centres in low-resource settings. The present study will be conducted in two different geographical settings in the Western and Eastern African countries of Guinea Bissau and Ethiopia. This improved clinical diagnostic pathway may improve case detection rates at primary healthcare level, ensuring prompt commencement of treatment, thereby diminishing transmission risk in the community and improving treatment outcomes. The Optimized Diagnostic Procedure (ODP) will utilize instructed sputum sampling and pooling as well as computer-aided detection (CAD) chest X-ray (CXR) and additional pooled sputum sample as well as non-sputum sampling (faecal and a buccal/tongue swab and saliva) for GeneXpert Ultra PCR (Xpert) as state-of-the-art add-ons to the routine diagnostic pathway for TB. This adds to the key components of the WHO "End TB" strategy - early diagnosis - and if successful, may be rapidly approved by the WHO and implemented by governments globally with potentially major public health benefits. The study will be conducted in close liaison with the national Ministries of Health and TB programs in Guinea-Bissau and Ethiopia. This will facilitate any relevant findings to be taken forward for implementation into policy and practice. Capacity development, training and educational activities will be closely aligned to this study.
Pulmonary Tuberculosis (TB) remains a significant global health concern, particularly in low- and middle-income countries (LMIC), where resources for healthcare are often limited. While CXR is the standard imaging modality for TB diagnosis, its sensitivity and specificity can vary depending on factors such as the stage of the disease and the quality of the image obtained. This study endeavors to assess the diagnostic precision of Chest Ultrasound (CUS) relative to Chest X-ray (CXR) and CAD score in the detection of Pulmonary Tuberculosis (TB) among both index cases and household contacts.
1. Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen (LJ) media culture to choose the best available test for the diagnosis of TB. 2. To assess the GeneXpert MTB/RIF assay performance in detection of Mycobacterium tuberculosis in smear-negative sputum samples.
The study is an evaluation of the diagnostic performance of different tests and their association in order to confirm or exclude active tuberculosis.
This study is designed to further strengthen the clinical application evidence of BaidiZiyin Pill and ShenqiYifei Pill in the treatment of tuberculosis. To be included in the initial treatment of pulmonary tuberculosis patients, on the basis of standardized Western medicine treatment, BaidiZiyin Pills and ShenqiYifei Pills will be used to evaluate the clinical efficacy and safety of their products. 1. Evaluate the improvement of symptoms in the adjuvant treatment of newly treated pulmonary tuberculosis with BaidiZiyin Pill and ShenqiYifei Pill. 2. Explore the sputum negative conversion time and sputum negative conversion rate of BaidiZiyin Pill and ShenqiYifei Pill as adjunctive treatments for newly treated pulmonary tuberculosis. 3. Explore the protective effects of BaidiZiyin Pill and ShenqiYifei Pill on adverse reactions caused by chemotherapy.