Condition category
Infections and Infestations
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
19/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard (Dick) Menzies

ORCID ID

Contact details

Montreal Chest Institute
Respiratory Epidemiology Unit
3650 St. Urbain
Room K1.24
Montreal
H2X 2P4
Canada
+1 (0)514 934 1934 ext. 32128
dick.menzies@mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00170209

Protocol/serial number

MCT-44154

Study information

Scientific title

Randomised clinical trial of four months rifampin versus nine months INH for the treatment of latent Tuberculosis

Acronym

Study hypothesis

1. To compare the rate of adverse events resulting in permanent discontinuation of study drug, with 4RIF or 9INH given as daily
2. To compare the rate of compliance/completion of the two arms
3. To compare costs, overall, and related to adverse events, of the two regimens

As of 25/02/2009 this record was updated to include an amendment to the overall trial end date; the initial overall trial end date at the time of registration was 30/09/2006.

Ethics approval

Research Ethics Board of the McGill University Health Centre (MUHC), Montreal Chest Institute, Montreal, QC, 18/04/2001

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Latent tuberculosis (TB) Infection

Intervention

One arm will receive nine months of isoniazid (INH) - the current standard therapy for this condition. The other group will receive four months of daily self-administered rifampin - a currently recommended alternative.

Trial details received: 12/09/2005

Intervention type

Drug

Phase

Not Applicable

Drug names

Rifampin, isoniazid

Primary outcome measures

Major adverse events requiring permanent discontinuation of study drug

Secondary outcome measures

1. Minor side effects
2. Compliance
3. Costs of Therapy

Overall trial start date

01/04/2001

Overall trial end date

30/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Close or casual contact of an active case pulmonary Tuberculosis (TB)
2. Aged 18 years and older, either sex
3. Documented tuberculin conversion within five years
4. Human immunodeficiency virus (HIV) positive, or other immune suppressed condition (e.g. corticosteroid therapy)
5. Apical/upper lobe fibronodular disease (with area greater than 2 cm^2), or other radiographic abnormalities
6. Underweight, diabetes, renal failure, or other medical risk factors
7. Recent (less than two years) arrival from country/region with TB incidence greater than 100/100,000

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1260 (847 recruited as of 30/01/2007 - end of recruitment)

Participant exclusion criteria

1. Low risk reactors
2. Patients who were contacts of known INH resistant case
3. Known HIV-infected individuals on triple anti-retroviral therapy
4. Women of child bearing age taking oral contraceptives
5. Patients on any other medication with clinically important drug interaction with INH or RIF

Recruitment start date

01/04/2001

Recruitment end date

30/01/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Montreal Chest Institute
Montreal
H2X 2P4
Canada

Sponsor information

Organisation

The Research Institute of the McGill University Health Centre (Canada)

Sponsor details

1650 Cedar Avenue
Montreal
H3G 1A4
Canada
-
emil.skamene@muhc.mcgill.ca

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44154)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19017587
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20627913

Publication citations

  1. Results

    Menzies D, Long R, Trajman A, Dion MJ, Yang J, Al Jahdali H, Memish Z, Khan K, Gardam M, Hoeppner V, Benedetti A, Schwartzman K, Adverse events with 4 months of rifampin therapy or 9 months of isoniazid therapy for latent tuberculosis infection: a randomized trial., Ann. Intern. Med., 2008, 149, 10, 689-697.

  2. Results

    Aspler A, Long R, Trajman A, Dion MJ, Khan K, Schwartzman K, Menzies D, Impact of treatment completion, intolerance and adverse events on health system costs in a randomised trial of 4 months rifampin or 9 months isoniazid for latent TB., Thorax, 2010, 65, 7, 582-587, doi: 10.1136/thx.2009.125054.

Additional files

Editorial Notes