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U.S. Department of Health and Human Services

  

This is an archived document. The links are no longer being updated.

TB Notes 3, 2003

UPDATE FROM THE CLINICAL AND HEALTH SYSTEMS RESEARCH BRANCH

Tuberculosis Trials Consortium (TBTC) Update

US Public Health Service Study 27

On January 13, 2003, and April 22, 2003, a CDC central institutional review board (IRB) approved the protocol for Study 27, a new TBTC multicenter clinical trial, for North American and international TBTC sites, respectively. Enrollment of patients in North America began in July 2003. The trial will also involve collaboration with the Tuberculosis Research Unit of Case Western Reserve University and will recruit study patients in Kampala, Uganda, where enrollment will also begin in August 2003. This arrangement represents the first time that TBTC has undertaken a tuberculosis treatment trial in Africa.

Study 27 is a double-blind, placebo-controlled comparison of the efficacy and tolerability of moxifloxacin (a newer-generation fluoroquinolone antibiotic) with ethambutol when each is used with isoniazid, rifampin, and pyrazinamide during the initiation phase of treatment of pulmonary tuberculosis. Implementation of Study 27 also involves collaboration with Bayer Pharmaceuticals, the maker of moxifloxacin, with whom CDC signed a Cooperative Research and Development Agreement in March 2003. Since moxifloxacin is currently approved only for short-duration treatment of community-acquired respiratory tract infections, its use for Study 27 in the treatment of tuberculosis required CDC to obtain Investigational New Drug approval from FDA. Study 27 will require a total enrollment of 300 patients and is expected to take 3 years to complete.

Questions regarding patient referrals, participating sites, and whether a patient qualifies for the study can be directed to CHSRB (404.639.8123) or Philip Spradling, MD, Project Officer at (404) 639-5346 or pps9@cdc.gov.

óReported by Philip R. Spradling, MD
Div of TB Elimination

Sites participating in Study 27:
• Boston University Medical Center, Boston, MA
• Case Western Reserve Univ./Makerere Univ., UGANDA
• Columbia University, New York, NY
• Denver Health and Hospitals, Denver, CO
• Emory University, Atlanta, GA
• Harborview Medical Center, Seattle, WA
• Harlem Hospital Center, New York, NY
• Johns Hopkins Univ Sch of Med, Baltimore, MD
• Los Angeles Cnty, USC Med Cn, Los Angeles, CA
• Montreal Chest Institute, Montreal, Quebec, CANADA
• New York University School of Medicine, New York, NY
• South Texas Hospital, Harlingen, TX
• Univ. of British Columbia, Vancouver, BC, CANADA
• Univ. of California/San Diego, San Diego, CA
• Univ. of California/San Francisco, San Francisco, CA
• Univ. of Manitoba, Winnipeg, Manitoba, CANADA
• Univ. of Medicine and Dentistry of New Jersey, Newark, NJ
• Univ. of North Tx Health Sci Cn, Fort Worth, TX
• VAMC Hines, IL
• VAMC Houston, TX
• VAMC San Antonio, TX
• VAMC Washington, DC

 


Released October 2008
Centers for Disease Control and Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination - http://www.cdc.gov/tb

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