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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 98
- Locations
- 23
- Primary Endpoint
- Combined endpoint of bacteriologic plus clinical failure and relapse within 2 years of completing treatment among patients with isoniazid-resistant tuberculosis and among patients enrolled with intolerance to isoniazid
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Rifampin+PZA+Ethambutol
6 mos of intermittent (2 or 3 times weekly) therapy with REZ
Intervention: Rifampin (Drug)
Rifampin+PZA+Ethambutol
6 mos of intermittent (2 or 3 times weekly) therapy with REZ
Intervention: Pyrazinamide (Drug)
Rifampin+PZA+Ethambutol
6 mos of intermittent (2 or 3 times weekly) therapy with REZ
Intervention: Ethambutol (Drug)
Rifampin+PZA+Ethambutol
6 mos of intermittent (2 or 3 times weekly) therapy with REZ
Intervention: REZ (Drug)
Outcomes
Primary Outcomes
Combined endpoint of bacteriologic plus clinical failure and relapse within 2 years of completing treatment among patients with isoniazid-resistant tuberculosis and among patients enrolled with intolerance to isoniazid
Time Frame: 30 mos
Secondary Outcomes
- Bacteriologic failure or relapse in patients with resistance to streptomycin(30 mos)
- Bacteriologic failure or relapse among patient with history of prior treatment(30 mos)
- Bacteriologic failure or relapse by duration of isoniazid received(30 mos)
- Occurrence and timing of toxicities and drug intolerances(6 mos)
- Occurrence of acquired resistance(30 mos)
- Proportion with documented conversion of 8-week sputum cultures(8 wks)
- Bacteriologic failure or relapse among patients with positive 8-week sputum cultures(30 mos)
- Time to completion and the frequency of successful completion(6 mos)