Tuberculosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed pericardial effusion on echocardiography Evidence of definite or probable tuberculous pericarditis Patient to have been on antituberculosis treatment for less than 1 week prior to enrolment into the trial
Exclusion criteria
Exclusion criteria: Presence of an alternative cause of pericardial disease, e.g. penetrating chest trauma in the previous 12 months and malignancy. Use of corticosteroids within the previous month. Hypersensitivity to the Mycobacterium w vaccine. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined outcome of cardiac tamponade requiring pericardial drainage, pericardial constriction, or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of immunomodulatory treatment measured by effect on opportunistic infections ;Long-term feasibility which will be assessed by looking at patient enrollment and patient completion of follow-up.;Rate of Immune reconstitution disease | — |
Countries
India, Mozambique, Nigeria, South Africa
Contacts
Trial Coordinator