Dick Menzies, MD, MSc; Richard Long, MD; Anete Trajman, MD, PhD; Marie-Josée Dion, MSc; Jae Yang, MD; Hamdan Al Jahdali, MD; Ziad Memish, MD; Kamran Khan, MD, MPH; Michael Gardam, MD; Vernon Hoeppner, MD; Andrea Benedetti, PhD; Kevin Schwartzman, MD, MPH
Acknowledgment: The authors are deeply indebted to Drs. George Comstock (deceased), Kevin Elwood, Richard O'Brien, and Michael Lauzardo for serving as the independent review panel and the data safety monitoring board for this study. The authors thank Dr. Eric Rousseau and his team at the University of Sherbrooke for developing the Web-based registration and randomization software. The authors also thank the staff of the many tuberculosis clinics involved.
Grant Support: From the Canadian Institutes of Health Research (grant MCT#44154). Dr. Menzies currently holds a Chercheur National Salary Award, and Dr. Schwartzman holds a Chercheur Boursier Clinicien Award from the Fonds de recherche en santé du Québec. Dr. Trajman receives salary support from the International Clinical, Operational, and Health Services Research Training Award for AIDS and Tuberculosis, the Fogart International Center, National Institutes of Health grant 5U2 R TW006883-03.
Potential Financial Conflicts of Interest: None disclosed.
Reproducible Research Statement:Study protocol: Available at http://www.mcgill.ca/recru/researchers/menzies/. Statistical code and data set: Will be available from Dr. Menzies (e-mail, firstname.lastname@example.org) after 1 September 2011 on written request and after establishing written agreement.
Requests for Single Reprints: Dick Menzies, MD, MSc, Montreal Chest Institute, 3650 St-Urbain, Room K1.24, Montreal, Quebec H2X 2P4, Canada; e-mail, email@example.com.
Current Author Addresses: Drs. Menzies, Benedetti, and Schwartzman and Ms. Dion: Montreal Chest Institute, 3650 St-Urbain, Montreal, Quebec H2X 2P4, Canada.
Dr. Long: Room 8325, Aberhart Hospital, 11402 University Avenue, Edmonton, Alberta T6G 2J3, Canada.
Dr. Trajman: Rua Macedo Sobrinho 74/203, Humaitá, Rio de Janeiro 22271-080, Brazil.
Dr. Yang: St. Michael's Hospital, 30 Bond Street, 6-045 Bond Wing, Toronto, Ontario M5B 1W8, Canada.
Drs. Al Jahdali and Memish: King Saud Bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Khashm Alaan, PO Box 22490, Riyadh 11426, Saudi Arabia.
Dr. Khan: Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute of St. Michael's Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8, Canada.
Dr. Gardam: Tuberculosis Clinic, University Health Network, 200 Elizabeth Street, 9 CSB, Toronto, Ontario M5G 2C4, Canada.
Dr. Hoeppner: Royal University Hospital, 101 College Drive, Saskatoon, Saskatchewan S0K 0Y0, Canada.
Author Contributions: Conception and design: D. Menzies.
Analysis and interpretation of the data: D. Menzies, A. Benedetti, A. Trajman, K. Khan, K. Schwartzman.
Drafting of the article: D. Menzies.
Critical revision of the article for important intellectual content: D. Menzies, R. Long, A. Trajman, A. Benedetti, H. Al Jahdali, Z. Memish, J. Yang K. Khan, M. Gardam, V. Hoeppner, K. Schwartzman.
Final approval of the article: D. Menzies, R. Long, A. Trajman, M.J. Dion, A. Benedetti, H. Al Jahdali, Z. Memish, K. Khan, M. Gardam, V. Hoeppner, K. Schwartzman.
Provision of study materials or patients: D. Menzies, R. Long, A. Trajman, M.J. Dion, J. Yang, H. Al Jahdali, Z. Memish, K. Khan, M. Gardam, V. Hoeppner.
Statistical expertise: D. Menzies, A. Benedetti.
Obtaining of funding: D. Menzies.
Administrative, technical, or logistic support: D. Menzies, M.J. Dion.
Collection and assembly of data: D. Menzies, A. Trajman, M.J. Dion.
ClinicalTrials.gov registration number: NCT00170209.
Menzies D, Long R, Trajman A, Dion M, Yang J, Al Jahdali H, et al. Adverse Events with 4 Months of Rifampin Therapy or 9 Months of Isoniazid Therapy for Latent Tuberculosis Infection: A Randomized Trial. Ann Intern Med. 2008;149:689-697. doi: 10.7326/0003-4819-149-10-200811180-00003
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Published: Ann Intern Med. 2008;149(10):689-697.
After detection and treatment of active tuberculosis cases, the next priority in tuberculosis control is the diagnosis and treatment of persons with latent tuberculosis infection (LTBI) who are at increased risk for active tuberculosis. Treatment of such individuals can provide individual and public health benefits (1–4). The current recommended standard therapy in most countries is 9 months of isoniazid therapy (4, 5). The drug has more than 90% efficacy if taken the entire 9 months (6), but completion rates under routine practice conditions are about 50% or less (7–9). Another important disadvantage of isoniazid therapy is the occurrence of serious adverse events, particularly drug-induced hepatitis (10). Drug-induced hepatitis was not recognized as a complication of isoniazid therapy in early trials involving more than 50 000 participants (11), but it was a frequent and potentially severe problem after isoniazid was recommended for tuberculosis prevention in 1970 (12) and was subsequently used more widely (13, 14). This complication makes close monitoring necessary, increasing costs.
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Infectious Disease, Mycobacterial Infections.
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