Assessing PA-824 for Tuberculosis (the APT Trial) (NCT02256696) | Clinical Trial Compass
CompletedPhase 2
Assessing PA-824 for Tuberculosis (the APT Trial)
South Africa157 participantsStarted 2015-04-29
Plain-language summary
Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic) over 12 weeks of treatment. Funding Source - FDA Office of Orphan Products Development (OOPD)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated sputum or Gene Xpert positive sputum sample. Patients having extra-pulmonary manifestations of tuberculosis, in addition to smear-positive pulmonary disease, are eligible for enrollment.
✓. Age \> 18 years
✓. . Weight ≥ 40 kg and ≤ 80 kg
✓. Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs)
✓. . Signed informed consent
✓. . HIV negative, or positive with CD4 ≥350 cells/cu mm and not currently taking or planning to take combination antiretroviral therapy for HIV during the study.
✓. Ability to adhere with study follow-up
Exclusion criteria
✕. Pregnant or breast-feeding
✕. Known intolerance or allergy to any of the study drugs
✕. Concomitant disorders or conditions for which isoniazid, rifampin, rifabutin, pyrazinamide, or ethambutol is contraindicated. These include severe hepatic damage, acute liver disease of any cause, allergy to the drug, and acute uncontrolled gouty arthritis.
✕. Current or planned therapy, during the intensive phase of TB therapy with cyclosporine or tacrolimus, which have unacceptable interactions with rifamycins.
What they're measuring
1
Time to Sputum Culture Conversion on Liquid Medium
Timeframe: 12 weeks
2
Number of Participants With Grade 3 or Higher Adverse Events
. Any medical or psychosocial condition, which, in the view of the study investigator, makes study participation inadvisable.
✕. Pulmonary silicosis
✕. Central nervous system TB
✕. ECG at screening with corrected QT interval (QTc) (Fridericia correction) interval \>450 ms or any clinically-significant, in the opinion of the investigator, ECG abnormality