The objective of the IMPPI study was to assess the effectiveness and safety of oral prednisolone or placebo and mycobacterium with immunotherapy or placebo in 1400 patients with tuberculous pericardial effusion.

This pilot study of 200 patients was to initially confirm the feasibility of conducting a large-scale multi-centre clinical trial in patients with tuberculous pericarditis in sub-Saharan Africa, and also to provide preliminary safety data.

Pirimary endpoints:

Composite of death, constriction, or cardiac tamponade requiring pericardial drainage.

Secondary endpoints:

  • Safety of immunomodulatory treatment
  • Long-term feasibility of conducting a multi-centre trial in Africa and India.

Endpoints are adjudicated

Study Type

Interventional - Drug

Study Design

Randomized, double-blind, treatment, placebo control, factorial assignment

NO. of Countries


NO. of Sites


NO. of Participants


Study Period




Lily and Ernst Hausmann Research Trust

Cadila Pharma, India

South African Medical Research Council

Canadian Institutes of Health Research (CIHR)

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