Effect of community-wide isoniazid preventive therapy on tuberculosis among South African gold miners (Thibela TB)
| ISRCTN | ISRCTN63327174 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63327174 |
| Secondary identifying numbers | #19790.02 |
- Submission date
- 25/04/2006
- Registration date
- 01/06/2006
- Last edited
- 24/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Gavin Churchyard
Scientific
Scientific
PO Box 61587
Marshalltown
Johannesburg
Gauteng 2107
South Africa
Study information
| Study design | Cluster, randomized, non-blinded controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | Tuberculosis |
| Intervention | 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). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Isoniazid |
| Primary outcome measure | Overall TB incidence in the final 12 months of follow up |
| Secondary outcome measures | 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) |
| Overall study start date | 19/06/2006 |
| Completion date | 19/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Around 70,000 overall |
| Key inclusion criteria | 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. |
| Key exclusion criteria | 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 |
| Date of first enrolment | 19/06/2006 |
| Date of final enrolment | 19/06/2010 |
Locations
Countries of recruitment
- South Africa
Study participating centre
PO Box 61587
Johannesburg
Gauteng 2107
South Africa
Gauteng 2107
South Africa
Sponsor information
Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE) (USA)
Charity
Charity
Johns Hopkins Center for Tuberculosis Research
1820 Lancaster Street/Suite 300
Baltimore, MD
21231
United States of America
| Website | http://www.tbhiv-create.org |
|---|---|
"ROR" |
https://ror.org/00za53h95 |
Funders
Funder type
Charity
Bill and Melinda Gates Foundation - Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE), reference number: 19790.02
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/01/2014 | Yes | No |
