Name (Synonyms) | Correlation | |
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drug2025 | PET/CT Scan Wiki | 1.00 |
drug2668 | Sputum collection Wiki | 1.00 |
drug3021 | Urine collection Wiki | 1.00 |
drug1481 | Isoniazid, Rifampicin, Pyrazinamide and Ethambutol Wiki | 1.00 |
drug2551 | Saliva collection Wiki | 0.45 |
Name (Synonyms) | Correlation | |
---|---|---|
D014397 | Tuberculosis, Pulmonary NIH | 1.00 |
D014376 | Tuberculosis NIH | 0.71 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
Background: Tuberculosis (TB) is a bacterial lung infection. Typical treatment using anti-TB drugs lasts about 6 months. Some people with less severe TB might not need to take the drugs that long. Researchers think a PET/CT lung scan along with estimating how much TB is in the lungs might show who will be cured after only 4 months of treatment. Objective: To demonstrate that 4 months of treatment is not inferior to 6 months of treatment for people with less severe TB. Eligibility: People 18-75 years old who have TB treatable with standard TB drugs Design: Participants will be screened with: Medical history Physical exam Blood and urine tests HIV test Sputum sample: Participants will be asked to cough sputum into a cup. Chest x-ray Participants will start TB drugs. They will have visits at weeks 1, 2, 4, 8, 12, and about 6 more times during the 18-month study. Visits include: Sputum samples Physical exam Blood tests PET/CT scans at 2-3 visits: Participants fast for about 6 hours before the scan. Participants get FDG, a type of sugar that gives off a small amount of radiation, through an arm vein. They lie on a table in a machine that takes pictures of the body. Chest x-rays at 1-2 visits Participants who we believe are likely to be cured at 4 months will be randomly assigned to get either 6 months of treatment or 4 months of treatment. Participants may be asked to join a substudy using their sputum samples or additional blood tests.
Description: Estimation of the lower bound of a one-sided 95% confidence interval of the difference in success rates between arms B and C. If the lower bound is greater than -7%, this will be evidence that the treatment-shortening arm is not inferior to the standard duration arm.
Measure: Comparison of the rate of treatment success at 18 months (after treatment initiation) between Arms B and C. Time: 18 monthsDescription: The difference (and 95% confidence interval) in treatment success rates between a combined A+B Arm (with Arm A participants selected to represent a true 6-month standard of care population) and a combined Arm A+C (with the remaining Arm A participants selected to represent a treatment shortening strategy arm, and no overlap in Arm A participants assigned to B and C).
Measure: Radiologic, Immunologic and microbiologic measures Time: 18 months