Personalized Rifampin Dosing Trial Using Urine Testing for Drug-Sensitive Pulmonary Tuberculosis A Study of Safety and Effectiveness in Adults and Children at Haydom Lutheran Hospital, Tanzania

What this Trial Is About

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.

Precision Rifampin Trial for Personalized Dosing