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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
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
-
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.
-
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.