Condition category
Infections and Infestations
Date applied
25/04/2006
Date assigned
01/06/2006
Last edited
24/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.tbhiv-create.org

Contact information

Type

Scientific

Primary contact

Prof Gavin Churchyard

ORCID ID

Contact details

PO Box 61587
Marshalltown
Johannesburg
Gauteng 2107
South Africa

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

#19790.02

Study information

Scientific title

Acronym

Study hypothesis

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

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

Study design

Cluster, randomized, non-blinded controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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 names

Isoniazid

Primary outcome measures

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 trial start date

19/06/2006

Overall trial end date

19/06/2010

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Around 70,000 overall

Participant 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

Recruitment start date

19/06/2006

Recruitment end date

19/06/2010

Locations

Countries of recruitment

South Africa

Trial participating centre

PO Box 61587
Johannesburg
Gauteng 2107
South Africa

Sponsor information

Organisation

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

Sponsor details

Johns Hopkins Center for Tuberculosis Research
1820 Lancaster Street/Suite 300
Baltimore
MD
21231
United States of America

Sponsor type

Charity

Website

http://www.tbhiv-create.org

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation - Consortium to Respond Effectively to the AIDS-Tuberculosis Epidemic (CREATE), reference number: 19790.02

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24450889

Publication citations

  1. Results

    Churchyard GJ, Fielding KL, Lewis JJ, Coetzee L, Corbett EL, Godfrey-Faussett P, Hayes RJ, Chaisson RE, Grant AD, , A trial of mass isoniazid preventive therapy for tuberculosis control., N. Engl. J. Med., 2014, 370, 4, 301-310, doi: 10.1056/NEJMoa1214289.

Additional files

Editorial Notes