A Trial of Adjunctive Prednisolone and Mycobacterium with Immunotherapy in Tuberculous Pericarditis
To assess effectiveness and safety of oral prednisolone or placebo and Mycobacterium w immunotherapy or placebo in 1400 patients with tuberculous pericardial effusion. An internal pilot study of 200 patients will initially confirm the feasibility of conducting a large-scale multi-centre clinical trial in patients with tuberculous pericarditis in sub-Saharan Africa, and also provide preliminary safety data.
Randomized, double-blind (subject, caregiver, investigator, outcomes assessor), treatment, placebo control, factorial assignment, safety/efficacy.
Composite end-point of death, constriction, or cardiac tamponade requiring pericardial drainage. Secondary Endpoint: Safety of immunomodulatory treatment, Long-term feasibility of conducting a multi-centre trial in Africa and India. Endpoints are adjudicated
Salim Yusuf, Bongani Mayosi
University of Cape Town
Mayosi BM, Ntsekhe M, Bosch J, et al. Prednisolone and Mycobacterium indicus pranii in tuberculous pericarditis. N Engl J Med. 2014; 371:1121-30.