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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR2008060000892906 |
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Date of registration:
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11/03/2008 |
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Primary sponsor: |
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Public title:
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Pilot study of additional Prednisone and Mycobacterium w vaccine in tuberculosis affecting the outer membrane around the heart
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Scientific title:
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A Pilot Trial Of Adjunctive Prednisone And Mycobacterium W Immunotherapy In Tuberculous Pericarditis |
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Date of first enrolment:
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Target sample size:
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2008060000892906 |
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Study type:
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interventional |
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Study design:
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Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,
Randomised,
The random numbers will be computer generated in blocks of 10 and will follow unrestricted randomisation sequence,
This will follow central concealed randomisation by phone/fax from the project office.,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Bongani
Mayosi |
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Address:
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Department of Medicine, J Floor Old Main Building, Groote Schuur Hospital, Anzio Road
7925
Cape Town
South Africa |
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Telephone:
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27 21 406 6200 |
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Email:
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bongani.mayosi@uct.ac.za |
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Affiliation:
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Department of Medicine |
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Name:
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Liziwe
Figlan |
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Address:
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Department of Medicine, University of Cape Town, Old Main Building, Groote Schuur Hospital
7925
Observatory, Cape Town
South Africa |
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Telephone:
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0214066361 |
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Email:
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liziwe.figlan@uct.ac.za |
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
16 null
Age maximum:
100 null
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
null
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Primary Outcome(s)
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Combined outcome of cardiac tamponade requiring pericardial drainage, pericardial constriction, or death
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Secondary Outcome(s)
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Long-term feasibility which will be assessed by looking at patient enrollment and patient completion of follow-up.
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Rate of Immune reconstitution disease
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Safety of immunomodulatory treatment measured by effect on opportunistic infections
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Source(s) of Monetary Support
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University of Cape Town
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