Clinical Trial

High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis

Study acronym: IMPI-3
Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated August 21, 2025 (before its estimated September 15, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2020-08-17; most recent amendment 2025-08-15.
Status change: Active, Not Recruiting → Recruiting 2025-08-15
Status change: Recruiting → Active, Not Recruiting 2025-04-09
Status change: Not Yet Recruiting → Recruiting 2022-05-19
Status change: Recruiting → Not Yet Recruiting 2022-04-18
Status change: Not Yet Recruiting → Recruiting 2021-11-10
Trial Details
NCT Number NCT04521803
Lead Sponsor University of Cape Town
Conditions Tuberculous Pericarditis, HIV Status
Enrollment 60 participants
Start Date 2022-01-10
Primary Completion 2025-09-15 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-08-21