Rifampin versus isoniazid for the treatment of latent tuberculosis

ISRCTN ISRCTN41241584
DOI https://doi.org/10.1186/ISRCTN41241584
ClinicalTrials.gov number NCT00170209
Secondary identifying numbers 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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleRandomised clinical trial of four months rifampin versus nine months INH for the treatment of latent Tuberculosis
Study objectives1. 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) studiedLatent tuberculosis (TB) Infection
InterventionOne 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Rifampin, isoniazid
Primary outcome measureMajor adverse events requiring permanent discontinuation of study drug
Secondary outcome measures1. Minor side effects
2. Compliance
3. Costs of Therapy
Overall study start date01/04/2001
Completion date30/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1260 (847 recruited as of 30/01/2007 - end of recruitment)
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2001
Date of final enrolment30/01/2007

Locations

Countries of recruitment

  • Canada

Study participating centre

Montreal Chest Institute
Montreal
H2X 2P4
Canada

Sponsor information

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

1650 Cedar Avenue
Montreal
H3G 1A4
Canada

Email emil.skamene@muhc.mcgill.ca
ROR logo "ROR" https://ror.org/04cpxjv19

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44154)
Government organisation / National government
Alternative name(s)
Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location
Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
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