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
Protocol serial number	#19790.02
Sponsor	Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE) (USA)
Funder	Bill and Melinda Gates Foundation - Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE), reference number: 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

PO Box 61587
Marshalltown
Johannesburg
Gauteng 2107
South Africa

Study information

Primary study design	Interventional
Study design	Cluster, randomized, non-blinded controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Isoniazid
Primary outcome measure(s)	Overall TB incidence in the final 12 months of follow up
Key secondary outcome measure(s)	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)
Completion date	19/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	70000
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Study website	Study website	11/11/2025	11/11/2025	No	Yes