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Sponsored by: |
McGill University |
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Information provided by: | McGill University |
ClinicalTrials.gov Identifier: | NCT00170209 |
Although effective medications to treat and even prevent Tuberculosis (TB) have been available for over 40 years, TB remains the most important infectious cause of mortality among adults in the world. One of the cornerstones of control of this disease is detection and treatment of infection – while it is still latent, or dormant. Nine months of Isoniazid (INH) is highly effective to treat latent infection, and so is considered the standard therapy. However, this therapy is often unsuccessful, because the long duration reduces completion rates, and increases cost, and it is associated with serious, even fatal side effects. An alternate regiment, of four months Rifampin has been recommended by authoritative agencies as an alternative, but there is surprisingly little data regarding the safety and efficacy of this regimen. We propose a randomized trial to compare the safety and costs of this regimen with the standard of 9 months INH, having completed a preliminary trial which demonstrated that the 4RIF regimen had significantly better completion rates. If the safety of 4RIF can be shown to be as as good, or better, than 9INH, then we will continue with a larger scale trial to compare the efficacy of the two regimens in preventing future active cases of TB among persons with latent TB infection
Condition | Intervention | Phase |
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Latent TB Infection |
Drug: Isoniazide (drug), Rifampin (drug) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | Randomized Controlled Trial of 4 Months Rifampin Versus 9 Months INH for the Treatment of Latent TB |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dick Menzies, MD, MSc | 514-934-1934 ext 32128 | dick.menzies@mcgill.ca |
Contact: Marie-Josée Dion, MSc | 514-934-1934 ext 32162 | marie-josee.dion@mail.mcgill.ca |
Canada, Quebec | |
Montreal Chest Institute | Recruiting |
Montreal, Quebec, Canada, H2X 2P4 | |
Contact: Marie-Josée Dion, MSc 514-934-1934 ext 32162 marie-josee.dion@mail.mcgill.ca |
Principal Investigator: | Dick Menzies, MD, MSc | McGill University Health Center |
Study ID Numbers: | MCT-44154 |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00170209 |
Health Authority: | Canada: Health Canada |
Rifampin |
Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors Antitubercular Agents |
Infection Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Leprostatic Agents Antibiotics, Antitubercular |