|
ISRCTN
|
ISRCTN41241584
|
|
ClinicalTrials.gov identifier
|
NCT00170209
|
|
Public title
|
Rifampin versus isoniazid for the treatment of latent tuberculosis
|
|
Scientific title
|
Randomised clinical trial of four months rifampin versus nine months INH for the treatment of latent Tuberculosis
|
|
Acronym
|
N/A
|
|
Serial number at source
|
MCT-44154
|
|
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 end date of this trial; the initial end date at the time of registration was 30/09/2006.
|
|
Lay summary
|
|
|
Ethics approval
|
Research Ethics Board of the McGill University Health Centre (MUHC), Montreal Chest Institute, Montreal, QC gave approval on the 18th April 2001
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Canada
|
|
Disease/condition/study domain
|
Latent tuberculosis (TB) Infection
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/04/2001
|
|
Anticipated end date
|
30/12/2007
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
1260 (847 recruited as of 30/01/2007 - end of recruitment)
|
|
Interventions
|
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 Sept 2005
|
|
Primary outcome measure(s)
|
Major adverse events requiring permanent discontinuation of study drug
|
|
Secondary outcome measure(s)
|
1. Minor side effects
2. Compliance
3. Costs of Therapy
|
|
Sources of funding
|
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44154)
|
|
Trial website
|
|
|
Publications
|
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19017587
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20627913
|
|
Contact name
|
Dr
Richard (Dick)
Menzies
|
|
Address
|
Montreal Chest Institute
Respiratory Epidemiology Unit
3650 St. Urbain
Room K1.24
|
|
City/town
|
Montreal
|
|
Zip/Postcode
|
H2X 2P4
|
|
Country
|
Canada
|
|
Tel
|
+1 514 934 1934 ext. 32128
|
|
Fax
|
+1 514 843 2083
|
|
Email
|
dick.menzies@mcgill.ca
|
|
Sponsor
|
The Research Institute of the McGill University Health Centre (Canada)
|
|
Address
|
1650 Cedar Avenue
|
|
City/town
|
Montreal
|
|
Zip/Postcode
|
H3G 1A4
|
|
Country
|
Canada
|
|
Fax
|
+1 514 934 8261
|
|
Email
|
emil.skamene@muhc.mcgill.ca
|
|
Date applied
|
26/09/2005
|
|
Last edited
|
09/08/2010
|
|
Date ISRCTN assigned
|
26/09/2005
|
