TBTC NAA Study: Pilot Study of Surrogate Markers for Outcome of TB Treatment

1. (1) Enrollment in another TBTC treatment study, or (2) Suspected or culture-confirmed pulmonary TB (designated "NAA2"). Acceptable as indicators of suspected tuberculosis -- culture -- will be a positive AFB smear or a positive M. tuberculosis NAA test for MTB.
2. (For NAA2 cases only): Collection of a sputum specimen for NAA processing, obtained in the interval from 14 days before, to 17 days after the start of anti-tuberculosis treatment.

3. Physician recommendation and patient willingness to receive tuberculosis therapy as described in another TBTC treatment trial or in accordance with CDC/ATS recommendations as outlined below:

   Induction phase therapy will be initiated with 4-drugs (isoniazid, PZA, rifamycin and either ethambutol or streptomycin) by directly observed therapy (DOT).

   • The induction regimen:

     1. Induction regimens must have at least 40 DOT doses (if daily) or at least 56 DOT daily dose equivalents (if twice weekly). No more than 2 of every 7 total doses may be self-administered. Total induction doses (both DOT and self-administered) should not exceed 70. Induction should be completed within 12 weeks
     2. The ethambutol or streptomycin may be discontinued if the patient continues on adequate induction therapy with INH, rifampin and PZA, and if the M. tuberculosis isolate is susceptible to INH and rifampin.
   • If this induction regimen is not tolerated by the patient, a rifampin-containing regimen compatible with CDC/ATS recommendations is an acceptable alternative.
4. Age 18 years or older
5. Willingness to practice effective contraception (if female and of child-bearing potential)
6. Provision of written informed consent. Signed by both the patient and investigator, in accordance with Institutional Review Board requirements

Exclusion Criteria:

• Treatment with a drug(s) with high anti-mycobacterial activity for more than 15 days in the two months PRIOR to the start of anti-tuberculosis treatment, unless co-enrolled in TBTC Study 23, TBTC Study 24 or another TBTC treatment study.
• Patients with only extrapulmonary tuberculosis, unless co-enrolled in TBTC Studies 23, TBTC Study 24, or another TBTC treatment study.
• Skeletal tuberculosis
• Silicotuberculosis
• Patient intolerance of rifamycins, or MTB resistance to rifamycins
• Pregnancy or breast feeding