Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2008060000892906 Date of Approval: 24/04/2009
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pilot study of additional Prednisone and Mycobacterium w vaccine in tuberculosis affecting the outer membrane around the heart
Official scientific title A Pilot Trial Of Adjunctive Prednisone And Mycobacterium W Immunotherapy In Tuberculous Pericarditis
Brief summary describing the background and objectives of the trial Pericardial tuberculosis is a severe type of tuberculosis that lead to death of almost 1 in every 4 affected people despite the use of available tuberculosis medication. The number of people with this type of TB is increasing particularly in Africa and India due to the HIV epidemic. There is an urgent need for additional treatment to reduce the number of deaths resulting from this disease.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) IMPI075
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2009
Actual trial start date 01/01/2009
Anticipated date of last follow up 28/02/2012
Actual Last follow-up date 28/02/2014
Anticipated target sample size (number of participants) 1400
Actual target sample size (number of participants) 1400
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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. Masking/blinding used
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. Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo wk 1: 120 mg/day; wk 2: 90mg/day; wk 3: 60 mg/day; wk 4: 30 mg/day; wk 5: 15 mg/day; wk 6: 5 mg/day 6 weeks Prednisone and placebo will be supplied as 5 mg identical tablets and given at a dosage of 120 mg/day in the first week, followed by 90 mg/day in the second week, 60 mg/day in the third week, 30 mg/day in the fourth week, 15 mg/day in the fifth week, and 5 mg/day in the sixth week 700 Placebo
Experimental Group Mycobacterium w immunotherapy 5 doses of 0.1 ml of the vaccine intradermally on enrolment, at 2 weeks, 4 weeks, 6 weeks, and 3 months 3 months Patients enrolled in the Mycobacterium w experimental arm will receive 5 doses of 0.1 ml of the vaccine intradermally (on enrolment, at 2 weeks, 4 weeks, 6 weeks, and 3 months) 700
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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. Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/07/2007 Faculty of Health Sciences, Research Ethics Committee, University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Anzio Road Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Safety of immunomodulatory treatment measured by effect on opportunistic infections weeks 2, 4, 6 and months 3, 6, 12, 18 and 24
Secondary Outcome Long-term feasibility which will be assessed by looking at patient enrollment and patient completion of follow-up. weeks 2, 4, 6 and months 3, 6, 12, 18 and 24
Secondary Outcome Rate of Immune reconstitution disease weeks 2, 4, 6 and months 3, 6, 12, 18 and 24
Primary Outcome Combined outcome of cardiac tamponade requiring pericardial drainage, pericardial constriction, or death weeks 2, 4, 6 and months 3, 6, 12, 18 and 24
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Instituto Do Coracao Kenneth Kaunda Avenue,1111 Maputo Mozambique
Department of Cardiology, Baragwanath Hospital P.O Bertsham 2013 Johannesburg South Africa
Department of Medicine, All India Institute of Medical Sciences Room 3097, 3rd Floor, Ansar Nagar New Delhi India
University College Hospital Queen Elizabeth Road Ibadan, Oyo State Nigeria
Cardiac Clinic, Groote Schuur Hospital Anzio Road, Observatory Cape Town 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Cape Town Anzio Road, Observatory CapeTown 7925 South Africa
University of Cape Town Anzio Road, Observatory CapeTown 7925 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Anzio Road, Observatory Cape Town 7925 South Africa University
Primary Sponsor University of Cape Town Anzio Road, Observatory Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Professor Marek Smieja L424-St.Joseph's Hospital, 50 Charlton Avenue East Hamilton, Ontario L8N 4A6 Canada
Professor Marek Smieja L424-St.Joseph's Hospital, 50 Charlton Avenue East Hamilton, Ontario L8N 4A6 Canada
Professor Jimmy Volmink University of Stellenbosch Cape Town 7505 South Africa
Professor Jimmy Volmink University of Stellenbosch Cape Town 7505 South Africa
Dr Surendra Kumar Sharma Department of Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 India
Dr Surendra Kumar Sharma Department of Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 India
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bongani Mayosi Bongani.Mayosi@uct.ac.za +27214066200 Department of Medicine, J Floor, OMB, Groote Schuur Hospital, University of Cape Town, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Head Dept of Medicine
Role Name Email Phone Street address
Public Enquiries Veronica Francis veronic.francis@uct.ac.za 021 404 7674 Department of Medicine, University of Cape Town, Old Main Building, Groote Schuur Hospital
City Postal code Country Position/Affiliation
Observatory, Cape Town 7925 South Africa Trial Coordinator
Role Name Email Phone Street address
Scientific Enquiries Bongani Mayosi bongani.mayosi@uct.ac.za 27 21 406 6200 Department of Medicine, J Floor Old Main Building, Groote Schuur Hospital, Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Department of Medicine
REPORTING
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