Status:
COMPLETED
A Trial of Adjunctive Prednisolone and Mycobacterium w Immunotherapy in Tuberculous Pericarditis
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
Population Health Research Institute
Conditions:
Tuberculous Pericarditis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Human immunodeficiency virus (HIV) infection puts people at risk of opportunistic infections, such as tuberculosis. In Africa, the HIV epidemic has resulted in an increase in the number of cases of tu...
Detailed Description
Summary of research proposal Tuberculous pericarditis is one of the most severe forms of infection with Mycobacterium tuberculosis, causing death or cardiac disability in nearly half of those affected...
Eligibility Criteria
Inclusion
- Patients admitted with suspected tuberculous pericarditis will be eligible if they meet all three of the following criteria:
- A confirmed pericardial effusion on echocardiography;
- Evidence of definite or probable tuberculous pericarditis; and
- Within 1 week of starting of antituberculosis treatment.
Exclusion
- 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 or allergy to the Mycobacterium w vaccine.
- Pregnancy.
- Age \< 18 years.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT00810849
Start Date
December 1 2008
End Date
August 1 2014
Last Update
September 3 2014
Active Locations (1)
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1
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7925