drugset / Trial / NCT04521803

High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis

NCT04521803

Phase 2 Recruiting 60 enrolled University of Cape Town
RandomizedParallel-groupTriple-blindBasic science

Summary

The investigators hypothesise that high dose RIF (RIF35) will increase pericardial fluid RIF exposure and so enhance mycobacterial clearance, compared to standard of care dosing (RIF10). This Phase 2b randomized, placebo-controlled, double-blinded trial will evaluate the efficacy and safety of RIF 35mg/kg compared 10mg/kg, added to standard first-line ATT, for the treatment of PCTB.

Timeline

Start
2022-01-10
Primary completion
2025-09-15
Completion
2026-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifampin Small molecule 35 mg/kg Oral