At a glance
ClinicalIndex Comparison Record- ✓Age 18–60 years
- ✓Newly diagnosed pulmonary TB, confirmed by culture (≥10 colonies MTB on solid media OR positive BACTEC/MGIT liquid culture)
- ✓Negative sputum cultures after 2 months of anti-TB treatment
- ✓Chest X-ray and clinical findings consistent with TB
- ✕HIV-infected
- ✕Prior history of TB or prior TB treatment
- ✕Cavitary TB on initial chest X-ray
- ✕Drug-resistant TB (resistance to isoniazid, rifampicin, pyrazinamide, or ethambutol)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Study of Shortening the Duration of Standard Short Course Chemotherapy From 6 Months to 4 Months in HIV-non-infected Patients With Fully Drug-Susceptible, Non-cavitary Pulmonary Tuberculosis With Negative Sputum Cultures After 2 Months of Anti-TB Treatment
In Brief
A Phase 3 clinical trial evaluating Ethambutol, Isoniazid, and 2 other interventions for Tuberculosis. Completed, enrolled 394 participants across 3 sites in 3 countries.
Detailed Summary
Tuberculosis (TB) is a serious infection that can affect the lungs and other parts of the body. The usual way to treat TB is to take 4 medicines by mouth every day for 2 months, then take 2 of the same medicines for 4 more months, for a total of 6 months. The purpose of this study is to see if taking 4 months of TB medicines is as effective in curing some TB patients as taking 6 months of TB medicines. Study participants will include 758 human immunodeficiency virus (HIV)-non-infected individuals, ages 18-60. Participants will be treated with 4 standard drugs called isoniazid, rifampicin, pyrazinamide and ethambutol. All individuals will take TB medicines for at least 4 months. After 4 months of treatment, if no TB germs are growing in sputum samples, participants will be assigned to either stop taking TB medicine (4 months of treatment) or to continue taking TB drugs for 2 more months (6 months of treatment). Participants will be involved in study procedures for up to 30 months.
Study Details
Timeline
Interventions
Mycobacteriostatic agent given to prevent emergence of drug resistance to other 1st line drugs; dosages are 15-25 milligram (mg)/ kilogram (kg)/day (d).
Hydrazide of isonicotininc acid; antimicrobial activity is limited to mycobacteria where it inhibits the synthesis of mycolic acids.
1st line bactericidal agent; dosages are 15-30 mg/kg/d, up to 2 grams (gm)/d.
1st line bactericidal agent which inhibits deoxyribonucleic acid (DNA)-dependent ribonucleic acid (RNA) polymerase; dosages are 10 mg/kg/d (up to 600 mg/d).