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Research

Photo for TRIALS OF DISEASES SPECIFIC TO DEVELOPING COUNTRIES

TRIALS OF DISEASES SPECIFIC TO DEVELOPING COUNTRIES

Official Title

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

Status

Ongoing

Overview

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.

Study Design

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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

800

Number of Countries

1

Principal Investigator

Salim Yusuf