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Tuberculosis clinical trials

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NCT ID: NCT06409780 Not yet recruiting - Clinical trials for Tuberculosis, Pulmonary

Comparative Efficacy of CUS, CXR and CAD in TB Diagnosis in LMIC

CUSTB
Start date: May 5, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06409572 Not yet recruiting - Tuberculosis Clinical Trials

Study of GeneXpert Mycobacterium Tuberculosis/ Rifampicin (MTB/RIF) Versus the Routine Methods for Detection of Mycobacterium Tuberculosis

Start date: June 2024
Phase:
Study type: Observational

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.

NCT ID: NCT06401434 Not yet recruiting - Tuberculosis Clinical Trials

Evaluation of CAD-based Triage for CXR Interpretation During TB Screening

Start date: June 2024
Phase: N/A
Study type: Interventional

Clinical workflows which position computer-aided detection (CAD) software for chest X-ray interpretation during TB screening as a decision support tool for radiologists, with the aim of improving interpretation accuracy and/or efficiency, may prove to be a more acceptable use case than outright radiologist replacement. Freundeskreis Für Internationale Tuberkulosehilfe e.V. (FIT) will organize 80 community-based chest X-ray screening events for TB across three provinces of Viet Nam as part of a pragmatic clinical trial designed to assess the real-world impact a CAD software deployment. INSIGHT CXR CAD software (Lunit, South Korea) will be used to support CXR interprtation at half of the screening events (randomly selected) by automating the identification of normal CXR images before an on-site radiologist makes a final CXR interpretation (CAD-based triage use case). The other screening events will use only an on-site radiologist for CXR interpretation (usual care). Aims 1. Compare the difference in the proportion of chest X-ray images which are declared as abnormal by the on-site radiologist between the study arms 2. Compare the difference in the proportion of people diagnosed with TB using the Xpert MTB/RIF Ultra assay among those screened by chest X-ray between the study arms

NCT ID: NCT06392594 Not yet recruiting - Clinical trials for Tuberculosis, Pulmonary

Performance of Xpert MTB/RIF and XDR Assay for Diagnosis of Pulmonary Tuberculosis and Resistant Pulmonary TB

Start date: April 23, 2024
Phase:
Study type: Observational

To determine how accurate Xpert MTB/RIF and XDR for diagnosis of pulmonary TB and Rifampicin resistance

NCT ID: NCT06390969 Not yet recruiting - Pleural Effusion Clinical Trials

TBP Survey Among Respiratory Physicians

Start date: June 1, 2024
Phase:
Study type: Observational

Tuberculosis is a major infectious disease with a high mortality burden in the Asia-Pacific region and worldwide. Among various types of extrapulmonary tuberculosis, tuberculous pleuritis (TBP) is amongst the most common manifestations. TBP is also a major underlying cause among patients hospitalised with new-onset unilateral pleural effusion. The workup of TBP frequently involves thoracentesis to retrieve pleural fluid and pleural biopsy for microbiological and histological interpretations. However, the diagnostic accuracy of these tests is of unsatisfactory sensitivity, making diagnosing TBP challenging. In addition, certain tests, including pleural fluid adenosine deaminase (ADA), Mycobacterium tuberculosis polymerase chain reaction (MTB PCR), advanced biopsy procedures (e.g. real-time image-guided biopsy, pleuroscopy) are not readily available in developing regions due to scarcity of resources and lack of expertise. All these factors lead to heterogeneous practice in approaching new-onset pleural effusion, interpretation of pleural TB investigations, and timing of TBP treatment initiation among respiratory physicians in different Asia-Pacific regions. The proposed multinational survey aims to understand the real-world clinical practice in approaching patients with new-onset unilateral pleural effusion and diagnosing TBP in Asia-Pacific regions with intermediate to high TB burden. The results will reflect the current practice of diagnosing TBP, clinical and resource discrepancies in investigating TBP, management of TBP and help prioritise the need for further research in TBP

NCT ID: NCT06352970 Not yet recruiting - Pregnancy Related Clinical Trials

Effects of Tuberculosis Infection on Development and Function of the Placenta

Start date: May 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to understand how tuberculosis (TB) infection impacts the function and development of the placenta, and whether TB infection can contribute to pregnancy-related disorders through effects on the placenta. The main questions it aims to answer are: - Does TB infection affect the structure of the placenta? - Does TB infection affect the function of the placenta? Pregnant women attending delivery clinics in Addis Abeba, Ethiopia, will be enrolled and classified for TB infection using a blood-based test. We will compare the following outcomes between women with TB infection and women without TB infection: - Pathological lesions of the placenta - Gene and protein expression patterns linked to pregnancy-related disorders - Infant outcome at birth and at 6 weeks after birth

NCT ID: NCT06338462 Not yet recruiting - Tuberculosis Clinical Trials

Cali Sin Tos Aim 2

Start date: May 2024
Phase: N/A
Study type: Interventional

The overall objective of this Aim is to design and iteratively adapt a home-based, mHealth- and oral testing facilitated strategy for implementing tuberculosis (TB) contact tracing in Cali, Colombia. Investigators will employ an iterative, community-engaged, participatory co-design process to optimize the feasibility, acceptability, usability, and appropriateness of the mobile health (mHealth) and oral testing strategy, in preparation for a future, appropriately powered implementation-effectiveness trial. This protocol includes the baseline contact tracing protocol and the procedures for determining adaptations to the mHealth strategy (i.e., nominal group technique).

NCT ID: NCT06338215 Not yet recruiting - Depression Clinical Trials

Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality

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

The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years). The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes. Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine. Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases.

NCT ID: NCT06318416 Not yet recruiting - Tuberculosis Clinical Trials

Precision Rifampin Trial for Personalized Dosing

P-RIF
Start date: July 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Individual pharmacokinetic variability is an important driver of tuberculosis (TB) treatment failure particularly among undernourished populations, and that suboptimal serum drug concentrations are associated with delayed response to treatment, death, and acquired bacterial drug resistance. Serum drug exposures can be approximated by urine excretion as measured by spectrophotometry, replacing the need for specialized equipment for serum testing. Anti-TB pharmacokinetic variability has also been associated with enteric pathogen burden. The overall hypothesis is that urine spectrophotometry will identify people with below-target rifampin serum concentrations, which can be corrected to target levels after dose adjustment as confirmed by serum mass spectrometry. Therefore, this protocol includes a clinical trial to assess efficacy and safety of rifampin dose adjustment based on urinary excretion levels among adults and children who are being treated for drug-sensitive pulmonary TB at our longstanding collaborative research site in Haydom Lutheran Hospital, Tanzania.

NCT ID: NCT06314386 Not yet recruiting - Tuberculosis Clinical Trials

Systems Analysis and Improvement Approach to Prevent TB

SAIA-TB
Start date: January 6, 2025
Phase: N/A
Study type: Interventional

This randomized trial uses the evidence-based Systems Analysis and Improvement Approach (SAIA) adapted for tuberculosis (SAIA-TB) to assess the comprehensive tuberculosis (TB) care cascade across 16 clinics in rural Eastern Cape, South Africa to improve patient outcomes. The aims of this study are to: - Evaluate the effectiveness of SAIA-TB use in clinics on TB cascade outcomes for TB patients and with high-risk contacts - Determine the drivers of SAIA-TB implementation success or failure across clinics The investigators hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period.