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Tuberculosis clinical trials

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NCT ID: NCT06354257 Not yet recruiting - Tuberculosis Clinical Trials

A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age

Start date: April 5, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used.

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.

NCT ID: NCT06306430 Not yet recruiting - Tuberculosis Clinical Trials

Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis

uLAMTBFIA
Start date: April 2024
Phase:
Study type: Observational

Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU).

NCT ID: NCT06281834 Not yet recruiting - Latent Tuberculosis Clinical Trials

Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention

Start date: May 2024
Phase: Phase 1
Study type: Interventional

Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population.

NCT ID: NCT06272812 Not yet recruiting - Tuberculosis (TB) Clinical Trials

A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region.

Start date: September 2024
Phase: Phase 2
Study type: Interventional

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 interferon gamma release assay positive adolescents and adults aged 14-45 years, living in a TB endemic region.

NCT ID: NCT06253715 Not yet recruiting - Tuberculosis Clinical Trials

Shortened Regimen for Drug-susceptible TB in Children

SMILE-TB
Start date: September 30, 2024
Phase: Phase 3
Study type: Interventional

While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.