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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying how individual differences in how the body processes rifampin, a key tuberculosis TB drug, affect treatment success in children and adults with drug-sensitive pulmonary TB in Tanzania. The study focuses on using urine tests to measure rifampin levels as a simpler alternative to blood tests, aiming to adjust doses for better treatment outcomes. The trial also examines how gut infections may impact drug absorption and treatment response. Participants receive standard TB therapy with isoniazid, rifampin, pyrazinamide, and ethambutol. They are randomly assigned to two groups one with urine testing and possible rifampin dose adjustment at Day 14, and the other at Day 21. Urine spectrophotometry measures rifampin levels to guide dose increases if below target, with repeat testing and blood samples collected to confirm drug levels. Stool samples are also collected to study gut infections and their effect on rifampin. During the study, participants undergo urine and blood testing for rifampin levels, stool analysis, and clinical assessments including weight and sputum culture tests to monitor treatment progress. Safety is closely tracked through adverse event reports and blood tests for liver, kidney, and blood health. The main outcomes measured are rifampin levels in the blood at 21 days and any severe side effects within 56 days, with secondary outcomes tracking time to negative sputum cultures, weight changes, and intestinal health markers.

Age: 3Years +All GendersPhase 1
1 location
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Actively Recruiting

Tuberculosis TB remains a significant public health challenge in Tanzania, with many cases going undiagnosed and compounded by nutritional and financial barriers. This study aims to evaluate how adding a conditional cash transfer to the current facility-based TB screening approach affects TB screening rates among household contacts of people diagnosed with TB. The study will also assess the prevalence of undernutrition among these contacts and how undernutrition severity impacts the progression to active TB disease. The study is a prospective, interventional cohort design enrolling 360 people diagnosed with TB and their households over a 2-year period. It includes two phases a 12-month lead-in period observing standard facility-based household TB screening, followed by a phase offering conditional cash transfers to households once all household contacts complete TB screening. Households will be visited 2 months after enrollment to complete TB screening and anthropometric measurements, then followed for 2 years to monitor for new TB cases. Participants will be involved in TB screening visits, nutritional assessments, and follow-up monitoring over 2 years. Researchers will measure the completion of TB screening among household contacts within 2 months and track the development of active TB disease in contacts over a year. The study also evaluates the cost-effectiveness of conditional cash transfers in improving screening. Data collection includes demographic, nutritional, and socioeconomic factors to prioritize prevention efforts for those at highest risk.

All GendersPhase Not Applicable
1 location