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ISRCTN
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ISRCTN63327174
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ClinicalTrials.gov identifier
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Public title
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Effect of community-wide isoniazid preventive therapy on tuberculosis among South African gold miners (Thibela TB)
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Scientific title
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Acronym
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N/A
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Serial number at source
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#19790.02
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Study hypothesis
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Community-wide tuberculosis (TB) case-finding, treatment of active TB and TB preventive therapy are effective ways of rapidly reducing the burden of TB infection and disease, and can improve TB control in high human immunodeficiency virus (HIV) prevalence areas.
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Lay summary
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Ethics approval
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University of KwaZulu Natal ref AHR-1-200, approved 31/03/2006; London School of Hygiene and Tropical Medicine reference number: 3064, approved 02/12/2005
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Study design
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Cluster, randomized, non-blinded controlled trial
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Countries of recruitment
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South Africa
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Disease/condition/study domain
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Tuberculosis
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Participants - inclusion criteria
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All employees working within the study clusters are eligible for participation in the study as a whole, there are no specific exclusion criteria. Employees at clusters allocated to the intervention will be eligible for isoniazid preventive therapy.
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Participants - exclusion criteria
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1. Active TB (confirmed or suspected)
2. Weight less than 40 kg
3. Known or suspected hypersensitivity to isoniazid (INH)
4. Self-reported chronic liver disease or symptoms suggesting active hepatitis (jaundice, nausea, vomiting, right upper quadrant pain, dark urine, pale stools)
5. Alcohol use exceeding 28 units per week (men) or 21 units per week (women)
6. History of convulsions
7. History of psychosis
8. Peripheral neuropathy grade 2 or greater, as defined by the aquired immune deficiency syndrome (AIDS) clinical trials group classification of adverse events
9. Pregnancy and up to three months post-partum, or breastfeeding
10. Women of child bearing potential who decline to use contraception
11. Receipt of another investigational drug or product within the previous 30 days
12. Concomitant medication with phenytoin, carbamazepine, warfarin, theophylline, disulfiram, selective serotonin re-uptake inhibitor antidepressants (e.g. citalopram, fluoxetine, paroxetine, sertraline), oral ketoconazole or itraconazole
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Anticipated start date
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19/06/2006
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Anticipated end date
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19/06/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Around 70,000 overall
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Interventions
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Community-wide isoniazid preventive therapy. Individuals in the control clusters will receive a normal standard of TB care as per standards set down by the local TB control programme (an expanded directly observed treatments [DOTS] package, including TB preventive therapy targeted to high risk individuals, according to local policy).
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Primary outcome measure(s)
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Overall TB incidence in the final 12 months of follow up
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Secondary outcome measure(s)
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1. TB case notification rates during months 0 to 24 after enrolment
2. Trends in TB case notification rates
3. TB prevalence at the end of the follow-up period (as measured by sputum culture positivity)
4. All-cause mortality during months 0-24 of the follow-up period
5. Case notification rate of isoniazid-resistant TB
6. Safety of community-wide isoniazid preventive therapy (IPT)
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Sources of funding
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Bill and Melinda Gates Foundation - Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE), reference number: 19790.02
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Trial website
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http://www.tbhiv-create.org
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Publications
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Contact name
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Prof
Gavin
Churchyard
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Address
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PO Box 61587
Marshalltown
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City/town
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Johannesburg
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Zip/Postcode
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Gauteng 2107
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Country
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South Africa
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Sponsor
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Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE) (USA)
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Address
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Johns Hopkins Center for Tuberculosis Research
1820 Lancaster Street/Suite 300
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City/town
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Baltimore, MD
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Zip/Postcode
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21231
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Country
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United States of America
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Sponsor website:
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http://www.tbhiv-create.org
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Date applied
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25/04/2006
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Last edited
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01/06/2006
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Date ISRCTN assigned
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01/06/2006
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