Tuberculosis Clinical Trial
Official title:
TBTC Study 24: A Non-Comparative Study of the Efficacy of a Largely-Intermittent, Six-Month Tuberculosis Treatment Regimen Among Patients Who Will Not Receive Isoniazid Due to Initial Isoniazid Resistance or Intolerance
This study is a prospective, open-label, nonrandomized trial using a largely-intermittent, six-month tuberculosis treatment regimen among patients who will not receive isoniazid due to the presence of initial isoniazid resistance or intolerance. Subjects are enrolled after resistance or intolerance to isoniazid has been documented, and are treated for a total of six months (nine months if baseline chest x-ray shows cavitation and 2-month sputum culture is positive) with twice weekly or thrice weekly rifampin, ethambutol, and pyrazinamide.
Primary Objective:
To evaluate the efficacy of a directly-observed, largely-intermittent, six-month regimen of
rifampin, pyrazinamide, ethambutol among patients with culture confirmed isoniazid-resistant
M. tuberculosis.
Secondary Objectives:
To describe the rate, severity and timing of toxicities and drug intolerances associated
with this treatment regimen.
To describe the utility of this regimen among patients who are unable to continue the
standard 4-drug regimen due to the development of intolerance to isoniazid
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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