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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 12, 2005 | ||||||||
| Last Updated Date | September 12, 2005 | ||||||||
| Start Date ICMJE | April 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Randomized Clinical Trial of 4RIF Vs. 9INH for the Treatment of Latent TB | ||||||||
| Official Title ICMJE | Randomized Controlled Trial of 4 Months Rifampin Versus 9 Months INH for the Treatment of Latent TB | ||||||||
| Brief Summary | 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 |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study | ||||||||
| Condition ICMJE | Latent TB Infection | ||||||||
| Intervention ICMJE | Drug: Isoniazide (drug), Rifampin (drug) | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | April 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00170209 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | MCT-44154 | ||||||||
| Study Sponsor ICMJE | McGill University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | McGill University | ||||||||
| Verification Date | November 2004 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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