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Showing 1-17 of 17 trials
NCT06272812
A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in adolescents and adults aged 14-45 years, living in a TB endemic region.
NCT07419568
This study aims to address critical diagnostic and data gaps in tuberculosis (TB) care among pregnant and postpartum women in Guinea-Bissau, a high-burden, resource-limited setting. Recognising that current TB screening during antenatal care (ANC) relies largely on unstructured symptom questions, the study will integrate more systematic and innovative approaches into routine maternal health services. The project will implement the Bandim TBscore II as a structured triage tool to classify symptom severity and guide referrals. To strengthen diagnostic capacity, two novel tools will be evaluated: stool-based GeneXpert testing (a method recommended in children and explored here as a feasible alternative for pregnant women) and artificial intelligence-powered chest X-ray interpretation software designed to enhance TB detection where radiological expertise is lacking. The study will also generate comprehensive, population-based data on TB and TB infection (TBI) among pregnant, postpartum women and women of reproductive age in Guinea-Bissau. The results are intended to inform health policy, both locally and in high-income countries, by providing evidence to improve TB screening protocols and care for this vulnerable group. Ultimately, the study seeks to develop scalable strategies that can be replicated across low- and middle-income countries to advance maternal and child health and support global TB eradication efforts.
NCT07303699
The purpose of this study is to assess pharmacokinetic parameters of atorvastatin at different doses when combined with the standard first line tuberculosis (TB) treatment regimen in adults with drug sensitive pulmonary TB. The pharmacokinetics parameters will be correlated with Pharmcodynamic measures and a PK/PD model that will identify an optimal dosing regimen of atorvastatin that is appropriate for the treatment of pulmonary tuberculosis will be developed.
NCT07234929
The study titled "Effectiveness of Chat-based Mobile Application for Consultation (Zalo) in Improving Compliance with Follow-up Tests after Abnormal Chest X-ray Findings Interpreted by Artificial Intelligence" aims to evaluate whether digital communication can enhance patient adherence to follow-up evaluations after lung disease screening in Vietnam. Lung cancer and tuberculosis (TB) remain leading causes of morbidity and mortality in Vietnam. Despite advances in screening technologies, including low-dose CT and AI-assisted chest X-rays, many patients fail to follow up after receiving abnormal results, resulting in delayed diagnosis and treatment. Communication barriers, low health literacy, and limited consultation time are key factors behind this gap. Digital health tools such as chat-based mobile applications offer potential to strengthen post-screening engagement and improve health outcomes. This randomized controlled trial will be conducted at Nhan Dan Gia Dinh Hospital in Ho Chi Minh City between October 2025 and October 2026. Participants aged 40-62 years, who undergo routine chest X-ray screening interpreted by AI software (qXR by QURE.AI), will be randomly assigned to either the intervention or control group. All participants must have an active Zalo account. In the intervention group, participants will receive their AI-interpreted results and educational guidelines for lung cancer or TB through the research team's Zalo account. The guideline covers disease overview, diagnostic methods, follow-up recommendations, and lifestyle guidance. Participants may ask questions directly to doctors specializing in nutrition, respiratory medicine, and pulmonary pathology, with guaranteed responses within 4 hours during working hours and 10 hours after hours. Messages are also sent via email as backup. The hospital's IT department oversees the Zalo platform to ensure data security. In the control group, participants will receive only the doctor's conclusion and brief advice via Zalo and email. They will be invited to connect with the hospital's official Zalo account for general inquiries but will not receive further digital consultation. Follow-up calls will assess compliance. For positive or suspected cases, research staff will call one month after result notification to confirm whether participants completed follow-up tests. For negative cases, calls will occur at six months to check for new symptoms or additional imaging. Structured questionnaires will document reasons for compliance or noncompliance. The study does not provide additional diagnostic services; all follow-up costs are covered by participants or their health insurance. The primary outcome is the rate of compliance with recommended follow-up tests. The secondary outcome measures participants' responsiveness to follow-up phone calls. Statistical analyses will compare compliance rates between groups using chi-square or Fisher's exact tests and risk ratios with 95% confidence intervals. Sample size calculations estimate that 2,692 participants are required to detect a 10% improvement in follow-up compliance (from 85% to 95%) with 80% power and 5% significance. Randomization will use REDCap software with block sizes of 2-8. Interviewers conducting follow-up calls will be blinded to group allocation. Ethical approval will be obtained from the Nhan Dan Gia Dinh Hospital Ethics Committee, and the study will be registered at ClinicalTrials.gov. Data confidentiality will be strictly maintained, with all digital records password-protected and accessible only to authorized research members. This project is the first randomized controlled trial in Vietnam to evaluate the effectiveness of chat-based mobile consultation in improving post-screening compliance for lung diseases. It leverages Vietnam's high mobile phone penetration and the popularity of Zalo to create a scalable model for patient engagement. Expected benefits include improved communication, increased awareness of lung cancer and TB, reduced loss to follow-up, and faster diagnostic confirmation. The findings will provide scientific evidence for integrating digital communication into screening programs and contribute to national efforts to improve early detection and management of lung diseases.
NCT07167823
Empyema is a problem that thoracic surgeons deal in everyday practice. The main goal of treatment is evacuating the pus and fibrin deposits in the thoracic cavity for complete lung expansion. This study aims to report a detailed microbiological profile of patients operated for empyema thoracis and also correlate it with perioperative clinical outcomes. Patients who underwent surgery for empyema thoracis between January 2022 to June 2025 were included in the study. This study was carried out at two centers; Thoracic Surgery Department, Services Hospital Lahore. Patients were taken up for surgery after thorough preoperative evaluation. Perioperative outcomes were correlated with the results of microbiological analysis to evaluate their effect on clinical outcomes. This study highlights the emergence of Gram-negative organisms in bacterial empyema and emergence of multidrug resistance in tubercular empyema. Clinical outcome correlation revealed increased complications in culture-positive cases in both tubercular and nontubercular empyemas
NCT06796647
The aim of the study is to pilot the application of a novel ESAT6/CFP10 (C-TST) skin test in rheumatologic disease patients prior to initiation of treatment with biologic and/or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD). This is a prospective observational study involving the recruitment of patients with rheumatologic diseases who are planned for initiation of b/tsDMARD. Eligible patients would undergo skin testing by the Mantoux technique with purified protein derivative (PPD) RT23 on one forearm and C-TST on the other, alongside routine blood sampling for Interferon-Gamma Release Assay. The skin test results would be read within 48-72 hours afterwards. Treatment of TB infection would be provided in accordance with current clinical guidelines, followed by regular clinical monitoring for 2 years. Analyses involve performance evaluation of C-TST, and decision-analytical modelling incorporating multiple Markov process to evaluate the impact of management by LTBI testing methods on clinical outcomes and health care costs.
NCT07163143
People living in high TB burden communities who undergo active case finding for TB may have chest X-ray changes suggestive of TB but their sputum test can be negative for the TB bacteria or they are unable to provide a sputum sample. This means they have bacteriologically unconfirmed TB. These individuals often have minimal or no symptoms and face uncertainty in clinical management-either receiving full 24-weeks TB treatment or often being discharged without treatment, risking loss to follow-up. The RADIO-TB trial aims to address the following main questions in relation to people with bacteriologically unconfirmed TB. 1. What is the risk of progression if treatment is not immediately started but there is close and careful follow-up over 78 weeks? 2. If treatment is started immediately what is the shortest duration of TB treatment that is as effective as the standard 24-week TB treatment? 3. Are there better tests to confirm TB than the current routinely used, sputum-based tests? 4. What is the cost effectiveness of different treatment strategies and what might the impact on transmission be within communities? Participants in the trial will be randomized into six groups: five receiving immediate standard TB treatment of varying durations (8 to 24 weeks), and one receiving deferred treatment with close monitoring. Deferred treatment will be initiated only if clinical deterioration occurs or TB is later confirmed. Participants will be closely followed for 78 weeks with at least 11 clinic visits.
NCT04333485
TB Aftermath will compare effectiveness, cost-effectiveness and feasibility of two ACF strategies for detecting recurrent TB and provide evidence needed to implement and scale the preferred ACF strategy. The specific aims are: Primary Aim 1: To conduct a non-inferiority randomized trial to measure the comparative effectiveness of two potentially implementable ACF strategies within India's National TB Elimination Program (NTEP), conducted by existing NTEP healthcare workers (HCWs): (i) home-based ACF (HACF) and (ii) telephonic ACF (TACF). Primary Aim 2: To characterize implementation processes of the ACF strategies using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to inform future scale-up and sustainability. Primary Aim 3: To model the impact and cost effectiveness of the ACF strategies evaluated in the trial, and of potential alternative strategies for the targeting and timing of those strategies. Secondary Aim: To measure the association of the severity, chronicity and progression of post-TB lung impairment with recurrent TB disease.
NCT07069387
The gold standard for tuberculosis (TB) treatment support requires directly observed therapy (DOT), which means a trained health worker observes the patient swallow each dose of medication every day for 2 months. Despite the practice of DOT in Malaysia, 1 in 20 patients are loss-to-follow-up and non-adherent to treatment. Sub-optimal adherence due to poor treatment acceptability and social desirability promotes TB treatment failure, disease relapse, on-going transmission, drug resistance, and death. Telemedicine offers a flexible and less invasive option to support TB treatment adherence. Despite 97% internet and smartphone penetration rates, the practical implementation of digital adherence strategies to support and monitor TB treatment remains untested in Malaysia. The investigators propose to design, implement, and measure the effectiveness of a comprehensive, pharmacist-led digital solution for TB treatment support called CARE-TB which combines a package of asynchronous video-observed therapy, digital reminders, telecounselling and e-learning. In this multi-method effectiveness-implementation (Type 2) study using the Exploration, Preparation, Implementation and Sustainment (EPIS) framework, the investigators aim 1) To identify patient and provider-level facilitators and barriers to CARE-TB adoption via qualitative evaluation and to design a stakeholder-informed implementation strategy, (2) To assess effectiveness of CARE-TB strategy by evaluating (i) implementation outcomes, (ii) patient health outcomes, and (iii) service outcomes, and (3) To evaluate the cost-effectiveness of CARE-TB compared to standard of care from a societal perspective. This study will leverage digital platforms to expand the reach of TB adherence support, enhance adherence to TB treatment and improve treatment completion rates, while utilising existing personnel and resources in among the busiest TB treatment centres in the country.
NCT07003581
Background: MDR-TB (Multidrug Resistant tuberculosis) remains a major public health concern, especially in high-burden countries like Nepal. While individual risk factors are known, the cumulative impact of cardiometabolic on MDR-TB is not well understood. Methods and Findings: A health-facility-based, age- and sex-matched 1:2 case-control study will be conducted at DR-TB (Drug Resistant Tuberculosis) treatment centers in Gandaki Province, Nepal. MDR-TB patients (cases) and DS-TB patients (controls) will be enrolled. Cases will be defined as adults (≥18 years) with confirmed MDR-TB; controls will be adults with sputum-positive DS-TB (Drug Sensitive Tuberculosis). Data on sociodemographics, cardiometabolic risk factors (alcohol, tobacco, BMI, hypertension, diabetes), TB literacy, and treatment history will be collected using a structured, pretested questionnaire by trained medical officers. Data will be analyzed using SPSS v25. Binary logistic regression will be used to assess associations between risk factors and MDR-TB. Ethical approval will be obtained from the NHRC, and written informed consent will be obtained from all participants.
NCT07024836
This study is part of a broader programme of work to develop and pilot a randomised-controlled trial of new tests to identify people who will benefit most from preventive treatment for tuberculosis (TB). The aim of the current study is to explore factors affecting patient decisions to start preventive treatment. The specific objectives are to understand how patients make decisions about preventive treatment initiation for TB (stage 1); and to design and conduct a "discrete choice experiment" survey to further evaluate preferences (stage 2).
NCT06916962
Introduction: Tuberculosis (TB) remains an ongoing public health and socioeconomic challenge worldwide, especially in low- and middle-income countries such as Vietnam. Despite improvements in healthcare, TB still causes significant problems to those infected, especially within marginalized populations, including financial hardship, stigma, and mental health issues. This study aims to assess the effectiveness of a psycho-socioeconomic support intervention intended to improve treatment outcomes and reduce financial hardship faced by TB-affected households in Vietnam, measured through catastrophic costs. Methods: A hybrid type II effectiveness implementation study using a randomized control trial study design will be employed to evaluate the effectiveness and implementation of the intervention. The study will be conducted in 12 Vietnamese provinces across Northern, Central, and Southern regions, targeting areas with lower TB treatment success rates. Participants will be randomly assigned to either a control group, which will receive standard care, or an intervention group, which will receive cash transfers conditioned on participation in TB Club peer-support meetings. Data will be collected on the individual, household and district levels. Individual outcomes will include treatment success, health-related quality of life, TB-related stigma, and anxiety and depression. Household outcomes will include catastrophic cost incurrence, changes in financial capital and livelihoods, and TB service and universal health coverage (UHC) uptake. Implementation outcomes, by district, will include fidelity, satisfaction, participation, acceptability, and quality. Hypothesis: The study hypothesizes that providing financial and enhanced psychosocial support to people with TB will improve their treatment success and reduce the financial burden on TB-affected households.
NCT06702774
The goal of this study is to find out if using mobile vans with advanced technology can help reduce tuberculosis (TB) in rural Guangxi, China. The study will also examine how practical and cost-effective this approach is. The main questions it aims to answer are: 1) Does this new screening method lower the number of TB cases among high-risk groups? and 2) Is this method practical and acceptable for communities and healthcare workers? Participants in the study will: 1) undergo TB screening with mobile vans that use artificial intelligence (AI) to read chest X-rays, 2) answer a short questionnaire about their symptoms and health history, and 3) provide sputum samples for GeneXpert testing if needed. Some communities will receive the new screening method, while others will continue with usual care. Researchers will compare TB rates in the two groups over three years to see if the new approach works better for TB control. If successful, this method could be used to improve TB control in other areas.
NCT06700876
This is an observational study among approximately 160 end-stage renal disease patients on renal replacement therapy and post-living donor or deceased donor kidney transplant recipients. Investigators aim to assess the proportion of positive IGRA associated with symptom development, sputum Xpert MTB/RIF assay, and chest radiograph to define latent TB infection and subclinical TB among ESKD and renal transplant patients.
NCT04243031
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.
NCT03808636
The purpose of this study is to quantitate the speed of new culture method using 'Tika' media and compare with conventional systems
NCT01875952
The purpose of this study is to determine of once identified to the subjects infected with human immunodeficiency virus (positive VIH), to diagnose latent Tuberculosis, and to treat her with isoniazid for six months, measuring the production of Interferon range pre and posttreatment, to evaluate this way the result of the treatment on the immune response