Skip to content

Pilot study of additional Prednisone and Mycobacterium w vaccine in tuberculosis affecting the outer membrane around the heart

A Pilot Trial Of Adjunctive Prednisone And Mycobacterium W Immunotherapy In Tuberculous Pericarditis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR2008060000892906
Enrollment
1400
Registered
2009-04-24
Start date
2009-01-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

Sponsors

University of Cape Town
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Combined outcome of cardiac tamponade requiring pericardial drainage, pericardial constriction, or death

Secondary

MeasureTime 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

Public ContactVeronica Francis

Trial Coordinator

veronic.francis@uct.ac.za021 404 7674

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026