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TB Notes Newsletter

Return to TB Notes 3, 2005 Main Menu

No. 3, 2005

Clinical and Health Systems Research Branch Updates

Tuberculosis Trials Consortium (TBTC) Study 27 and 28 Update

TBTC Study 27, “An Evaluation of the Activity and Tolerability of Moxifloxacin During the First 2 Mos. of Treatment for Pulmonary Tuberculosis,” enrolled its first patient on July 25, 2003, and completed enrollment on March 14, 2005. Initially proposed to study 300 patients and to take 3 years to complete, the final enrollment was 336 patients.  Findings from preliminary analyses were presented at the TBTC meeting and American Thoracic Society (ATS) conference in May 2005.Approximately half of the enrollments occurred at the TBTC site in Kampala, Uganda, with the next largest enrollment occurring at the site in Durban, South Africa.

At the end of study enrollment, a large amount of generic ethambutol, good through November 2005, remained from the original bulk purchase from Versapharm. The surplus was offered to the African sites, whose high case rates would enable them to use it quickly in their routine clinical practice; the offer was accepted by the Uganda site. At the end of March, after completing the necessary paperwork, the CDC pharmacy sent 36,000 400 mg ethambutol tablets to Uganda, where they were very much appreciated. For readers who may wonder, matching placebo tablets that were also left over from Study 27 were destroyed according to CDC pharmacy drug services protocol.

TBTC Study 27 compared moxifloxacin with ethambutol during the first 2 months of therapy. Study 28, “Evaluation of a Moxifloxacin-Based, Isoniazid-Sparing Regimen for Tuberculosis Treatment,” will compare moxifloxacin with isoniazid during the first 2 months of therapy. It has been approved by the CDC IRB and is in the process of IRB review locally by consortium sites. Enrollment starts in early fall 2005.

Patients Enrolled in TBTC Study 27 by Site
See TB Notes No. 4, 2004, for more detail on TBTC Study 27 and 28 at

—Reported by Stefan Goldberg, MD
Div of TB Elimination


Released October 2008
Centers for Disease Control and Prevention
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