NCT00023374

TBTC Study 24: Intermittent Treatment of TB With Isoniazid Resistance or Intolerance

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	Rifampin	6mos REZ intermittent
DRUG	Pyrazinamide	6mos REZ intermittent
DRUG	Ethambutol	6mos REZ intermittent
DRUG	REZ	Rif+PZA+EMB given 2 or 3 times weekly for 6 months

Timeline

• Start date: 2000-08-01
• Primary completion: 2006-12-01
• Completion: 2010-12-01
• First posted: 2001-09-10
• Last updated: 2011-08-03

Locations

23 sites across 2 countries: United States, Canada