Health Condition 1: null- Tuberculosis
Conditions
Interventions
Intervention1: Rifapentine- Rifapentine is substituted for Rifampin as teh basis of 4 month treatment: 8 weeks of daily treatment with rifapentine 1200mg isoniazid 300mg pyrazinamide 1000mg,1500mg,200
Sponsors
The Centers for Disease Control and Prevention
Eligibility
Inclusion criteria
Inclusion criteria: Suspected pulmonary tuberculosis plus one or both of the following at least one sputum specimen positive for acid fast bacilli on smear microscopy OR at least one sputum specimen positive for M tuberculosis by Xpert MTBRIF testing, with semiquantitative result of medium or high and rifamycin resistance not detecte Age 18 years or older A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period Women of child-bearing potential who are not surgically sterilized must agree to practice an adequate method of contraception barrier method or non-hormonal intrauterine device or abstain from heterosexual intercourse during study drug treatment Documentation of HIV infection status For HIV positive individuals CD4 T Cell count greater than or equal to 100cells per mm3 based on testing performed at or within 30 days prior to screening Karnofsky score greater than or equal to 60 Written informed consent
Exclusion criteria
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 five days of treatment directed against active tuberculosis within 6 months preceding initiation of study drugs More than five days of systemic treatment with any one or more of the following drugs within 30 days preceding initiation of study drugs isoniazid rifampin rifabutin rifapentine ethambutol pyrazinamide kanamycin amikacin streptomycin capreomycin moxifloxacin levofloxacin gatifloxacin ofloxacin ciprofloxacin other fluoroquinolones ethionamide prothionamide cycloserine terizidone para-aminosalicylic acid linezolid clofazimine delamanid or bedaquiline Known history of prolonged QT syndrome Weight less than 40.0 kg Known allergy or intolerance to any of the study medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TB disease free survival at twelve months after study treatment assignment Proportion of participants with grade 3 or highter adverse events during study drug treatmentTimepoint: TB disease free survival at twelve months after study treatment assignment Proportion of participants with grade 3 or highter adverse events during study drug treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| TB disease free survival at twelve months after study treatment assignment Time to stable sputum culture conversion Speed of decline of sputum viable bacilli by automated MGIT days to detection Proportion of participants with grade 3 or highter adverse events during study drug treatmentTimepoint: Eighteen months after treatment assignment For or six months | — |
Countries
Brazil, China, Haiti, India, Kenya, Malawi, Peru, South Africa, Spain, Thailand, Uganda, United States of America, Viet Nam, Zimbabwe
Contacts
Public ContactDr N Kumarasamy
VHS YRGCARE Medical Centre
Outcome results
None listed