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Research

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IMPI

Official Title

A Trial of Adjunctive Prednisolone and Mycobacterium with Immunotherapy in Tuberculous Pericarditis

Status

Ongoing

Overview

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.

Study Design

Randomized, double-blind (subject, caregiver, investigator, outcomes assessor), treatment, placebo control, factorial assignment, safety/efficacy.

Primary Endpoint

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

Number of Patients

1400

Number of Sites

19

Number of Countries

8

Study Period

2009–2014

Principal Investigator

Salim Yusuf, Bongani Mayosi

Program Manager

Jackie Bosch

Research Coordinator

Laura Joldersma

Collaborators

University of Cape Town

Key Publications

Mayosi BM, Ntsekhe M, Bosch J, et al. Prednisolone and Mycobacterium indicus pranii in tuberculous pericarditis. N Engl J Med. 2014; 371:1121-30.