Phase 2b Trial Comparing High Dose and Standard Dose Rifampicin for Treating Effusive Tuberculous Pericarditis in Adults

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a higher dose of Rifampicin RIF35 compared to the standard dose RIF10 for treating effusive tuberculous pericarditis PCTB. This Phase 2b randomized, placebo-controlled, double-blinded trial aims to see if the higher dose increases Rifampicin exposure in the pericardial fluid and improves mycobacterial clearance. The study involves adults with pericardial TB, and participants are stratified by HIV status and PCF GX-Ultra status before randomization. Participants will receive either the standard anti-tuberculosis treatment alone or with added high-dose Rifampicin orally for 2 months, followed by a 4-month continuation phase with standard doses of Rifampicin and Isoniazid. Dosing is based on WHO weight bands, using fixed dose combination tablets and additional Rifampicin tablets to achieve equitable drug exposure across weights from 30 to 100 kg. Simulations guided the dosing to optimize exposure. During the study, participants will undergo assessments including measuring drug levels in pericardial fluid and mycobacterial load at 72 hours and 52 weeks. Researchers will also monitor mortality, re-accumulation of pericardial effusion, TB-IRIS, constrictive pericarditis, and cardiac magnetic resonance imaging results over 52 weeks. Safety and efficacy will be closely tracked throughout, with total participation covering at least one year.

High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis