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
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 |
|---|---|
| dick.menzies@mcgill.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2001 |
| Completion date | 30/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1260 (847 recruited as of 30/01/2007 - end of recruitment) |
| 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
H2X 2P4
Canada
Sponsor information
The Research Institute of the McGill University Health Centre (Canada)
University/education
University/education
1650 Cedar Avenue
Montreal
H3G 1A4
Canada
| emil.skamene@muhc.mcgill.ca | |
"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
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
