Rifampin versus isoniazid for the treatment of latent tuberculosis

ISRCTN	ISRCTN41241584
DOI	https://doi.org/10.1186/ISRCTN41241584
ClinicalTrials.gov (NCT)	NCT00170209
Protocol serial number	MCT-44154
Sponsor	The Research Institute of the McGill University Health Centre (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44154)

Submission date: 26/09/2005
Registration date: 26/09/2005
Last edited: 19/06/2015

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

Dr Richard (Dick) Menzies
Scientific

Montreal Chest Institute
Respiratory Epidemiology Unit
3650 St. Urbain
Room K1.24
Montreal
H2X 2P4
Canada

Phone	+1 (0)514 934 1934 ext. 32128
Email	dick.menzies@mcgill.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised clinical trial of four months rifampin versus nine months INH for the treatment of latent Tuberculosis
Study objectives	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(s)	Research Ethics Board of the McGill University Health Centre (MUHC), Montreal Chest Institute, Montreal, QC, 18/04/2001
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Rifampin, isoniazid
Primary outcome measure(s)	Major adverse events requiring permanent discontinuation of study drug
Key secondary outcome measure(s)	1. Minor side effects 2. Compliance 3. Costs of Therapy
Completion date	30/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1260
Key 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
Key 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
Date of first enrolment	01/04/2001
Date of final enrolment	30/01/2007

Locations

Countries of recruitment

Canada

Study participating centre

Montreal Chest Institute

Montreal
H2X 2P4
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/11/2008		Yes	No
Results article	results	01/07/2010		Yes	No