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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating a shorter, 6-month treatment regimen using high doses of rifampicin, isoniazid, linezolid, and pyrazinamide compared to the World Health Organization's standard 9-month treatment for tuberculous meningitis (TBM), a serious brain infection with high risk of death and severe neurological problems. This Phase II, randomized, open-label trial aims to evaluate the safety, drug levels, and long-term outcomes of this intensified 6-month therapy versus the standard treatment. Participants include adults and adolescents diagnosed with TBM, with treatment groups balanced by HIV status and disease severity.
Actively Recruiting
Researchers are evaluating new drug regimens for treating adults with drug-susceptible pulmonary tuberculosis (TB) in a Phase 2 adaptive, randomized, controlled, open-label trial. The study aims to determine if these novel treatments provide better early effectiveness compared to the standard combination of isoniazid, rifampicin, pyrazinamide, and ethambutol. The safety and tolerability of these regimens will also be assessed over an 8-week treatment period. Participants will receive one of several drug combinations, including standard therapy with isoniazid, rifampicin, pyrazinamide, and ethambutol, or experimental regimens containing drugs like bedaquiline, pretomanid, linezolid, TBI-223, and sutezolid. Dosing varies by drug, with most taken orally once daily, often with meals. The initial 8 weeks constitute the study treatment phase, followed by an 18-week continuation phase of standard care, making the total treatment duration 26 weeks. Throughout the study, participants will undergo regular assessments, including sputum cultures to measure bacterial growth rates during the first 6 weeks and monitoring for any serious side effects by week 8. Laboratory tests, chest x-rays, and performance scores will be used to evaluate health status. Participants will be followed for a total of 52 weeks, ensuring safety and treatment effectiveness are closely monitored.