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| Sponsor: | McGill University |
|---|---|
| Collaborator: |
Canadian Institutes of Health Research (CIHR) |
| Information provided by: | McGill University |
| ClinicalTrials.gov Identifier: | NCT00170209 |
Purpose
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 rate of adverse event resulting in permanent discontinuation of study drug, with 4 months of Rifampin or 9 months of Isoniazid given as daily, self-administered treatment for LTBI.
| Condition | Intervention | Phase |
|---|---|---|
|
Latent Tuberculosis Infection |
Drug: Isoniazide (drug), Rifampin (drug) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial to Compare Completion and Tolerability of 4 Months Rifampin (4 Rif) and 9 Months Isoniazid (9 INH) in Treatment of Latent TB in Children: |
| Enrollment: | 847 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Isoniazid
The standard therapy will be daily self-administered INH, 10-15 mg/kg/day for children (max=300mg/day) for 9 months (9INH). For children, dosing for both INH and RIF will be age and weight dependant, with highest doses for infants, and lowest for adolescents. A detailed dose chart - calculating doses by weight and age, and protocols for preparation of medications (crushing pills, mixing suspensions) will be prepared with expert input.
|
Drug: Isoniazide (drug), Rifampin (drug)
For children, dosing for both INH and RIF will be age and weight dependant, with highest doses for infants, and lowest for adolescents. A detailed dose chart - calculating doses by weight and age, and protocols for preparation of medications (crushing pills, mixing suspensions) will be prepared with expert input.
|
|
Active Comparator: Rifampin
The experimental arm will be daily self-administered RIF, 10-20 mg/kg/day for children(max=600mg/day) for 4 months (4RIF. For children, dosing for both INH and RIF will be age and weight dependant, with highest doses for infants, and lowest for adolescents. A detailed dose chart - calculating doses by weight and age, and protocols for preparation of medications (crushing pills, mixing suspensions) will be prepared with expert input.
|
Drug: Isoniazide (drug), Rifampin (drug)
For children, dosing for both INH and RIF will be age and weight dependant, with highest doses for infants, and lowest for adolescents. A detailed dose chart - calculating doses by weight and age, and protocols for preparation of medications (crushing pills, mixing suspensions) will be prepared with expert input.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Australia, New South Wales | |
| Woolcock Institute of Medical Research | |
| Sydney, New South Wales, Australia | |
| Benin | |
| Centre de Pneumophthysiologie | |
| Cotonou, Benin | |
| Brazil | |
| Universidade Gama Filho, Centro de Ciências Biológicas e da Saúde | |
| Rio de Janeiro, Brazil | |
| Canada, Alberta | |
| University of Alberta | |
| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
| British Columbia Centre for Disease Control | |
| Vancouver, British Columbia, Canada | |
| Canada, Quebec | |
| Montreal Chest Institute | |
| Montreal, Quebec, Canada, H2X 2P4 | |
| Guinea | |
| Service de Pneumo-Phtisiologie, Hopital National Ignace Deen | |
| Conakry, Africa, Guinea | |
| Indonesia | |
| Health Research Unit, Faculty of Medicine | |
| Bandung, West Java, Indonesia | |
| Saudi Arabia | |
| King Fahad National Guard Hospital | |
| Riyadh, Saudi Arabia | |
| Principal Investigator: | Dick Menzies, MD, MSc | McGill University Health Center |
More Information
| Responsible Party: | Dr. Dick Menzies/Principal Investigator, McGill University / McGill University Health Center |
| ClinicalTrials.gov Identifier: | NCT00170209 History of Changes |
| Other Study ID Numbers: | MCT-44154 |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 22, 2011 |
| Health Authority: | Canada: Health Canada |
|
Tuberculosis |
|
Tuberculosis Latent Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Isoniazid Rifampin Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Lipid Regulating Agents Antibiotics, Antitubercular Enzyme Inhibitors Leprostatic Agents Nucleic Acid Synthesis Inhibitors |