Effect of community-wide isoniazid preventive therapy on tuberculosis among South African gold miners (Thibela TB)

Completed

Conditions: Tuberculosis
Infections and Infestations

Registration Number: ISRCTN63327174

Lead Sponsor: Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE) (USA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 70000

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.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall TB incidence in the final 12 months of follow up

Secondary Outcome Measures

Name	Time	Method
1. TB case notification rates during months 0 to 24 after enrolment<br>2. Trends in TB case notification rates<br>3. TB prevalence at the end of the follow-up period (as measured by sputum culture positivity)<br>4. All-cause mortality during months 0-24 of the follow-up period<br>5. Case notification rate of isoniazid-resistant TB<br>6. Safety of community-wide isoniazid preventive therapy (IPT)