Evaluation of the Efficacy and Safety of a 4-month Daily Regimen (2HZPM/2HPM) for Treatment of Pu… (NCT04856644) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Evaluation of the Efficacy and Safety of a 4-month Daily Regimen (2HZPM/2HPM) for Treatment of Pulmonary TB
Taiwan333 participantsStarted 2020-01-01
Plain-language summary
The development of efficacious, safe, and shorter treatment regimens could significantly improve TB management and treatment success rates. This prospective, 3-year, single arm study is to evaluate the efficacy and safety of a short-course, 4-month regimen including isoniazid(H), pyrazinamide(P), rifapentine (P), and moxifloxacin(M) (2HZPM/2HPM) for the treatment of drug-susceptible, pulmonary tuberculosis, and compared with a historical control group receiving the standard six-month regimen.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Suspected newly diagnosed pulmonary TB plus one of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one sputum specimen positive for Mycobacterium tuberculosis by culture or "Gene Xpert MTB/RIF" testing, with rifamycin resistance not detected, OR c) histopathologic findings compatible with mycobacterial infection including a positive acid-fast stain
✓. Patient with a history of being untreated for 3 years after cure from a previous episode of TB can be included.
✓. Age 20 years or older
✓. For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening is required, and must agree to practice a barrier method of contraception during study drug treatment, or be surgically sterilized or have an intrauterine contraceptive device in place.
✓. Laboratory parameters performed at or within 14 days prior to enrollment:
✓. Patient signed a written informed consent
Exclusion criteria
✕. Pregnant or breast-feeding.
✕. Unable to take oral medications.
✕. Previously enrolled in this study.
✕. Received any investigational drug in the past 3 months.
✕. More than 14 days of systemic treatment with any antituberculous drugs preceding initiation of study drugs.
What they're measuring
1
TB disease free survival at 12 months
Timeframe: 12 months after study treatment assignment
2
Grade 3 or higher adverse events during study drug treatment
✕. Suspected or documented TB involving the central nervous system and/or bones and/or joints, and/or miliary tuberculosis and/or pericardial tuberculosis.