High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis

Recruiting Phase 2 Interventional Study
Tuberculous Pericarditis HIV Status
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Basic Science
Participants needed
60 (estimated)
Sponsor
University of Cape Town · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Aged \>18 years 2. Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole) 3. Consent to study participation including testing for HIV-1 (if HIV status is unknown) 4. Microbiologically…
Contacts

Mpumi U Maxebengula, BCom

0727633386

mpumi.maxebengula@uct.ac.za

CONTACT

Kishal Maxebengula, Dr

+27732515380

kishal.lukhna@uct.ac.za

CONTACT