Rifapentine-containing tuberculosis treatment shortening regimens(S31/A5349)
- Conditions
- Health Condition 1: null- Tuberculosis
- Registration Number
- CTRI/2018/07/014966
- Lead Sponsor
- The Centers for Disease Control and Prevention
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TB disease free survival at twelve months after study treatment assignment <br/ ><br>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 <br/ ><br>Proportion of participants with grade 3 or highter adverse events during study drug treatment
- Secondary Outcome Measures
Name Time Method TB disease free survival at twelve months after study treatment assignment <br/ ><br> <br/ ><br>Time to stable sputum culture conversion <br/ ><br>Speed of decline of sputum viable bacilli by automated MGIT days to detection <br/ ><br>Proportion of participants with grade 3 or highter adverse events during study drug treatmentTimepoint: Eighteen months after treatment assignment <br/ ><br>For or six months