A Pilot Trial of Adjunctive Prednisolone and Mycobacterium with Immunotherapy in Tuberculous Pericarditis
A preliminary clinical trial in which people who are on anti-tuberculosis treatment for pericardial tuberculosis will be randomly allocated to receive either prednisolone or a matching placebo tablet, or Mycobacterium w injection or placebo injection. To determine whether the use of corticosteroids or Mycobacterium w injection is safe and results in reduction in the death rate.
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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.