Tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
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 dire
Sponsors
Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE) (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall TB incidence in the final 12 months of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
South Africa
Outcome results
None listed