Phase
Condition
Lung Disease
Hiv
Treatment
Short-course regimen
Four-month regimen
Three-month regimen
Clinical Study ID
Ages 14-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age between 14 to 80 years;
- Male or female;
- Willing to provide signed informed consent, or parental consent and participantassent;
- Individuals with respiratory tract specimen (including sputum/bronchoalveolarlavage fluid/lung tissue) positive for acid-fast bacilli smear/culture/molecularamplification for M. tuberculosis;
- No unexplained TB-suggestive symptoms in the three months prior to screening,including cough lasting more than two weeks, night sweats, fever or weight loss;
- If non-menopausal woman, agree to use or have used effective contraception duringtreatment.
Exclusion
Exclusion Criteria:
- Combined extrapulmonary tuberculosis;
- Induviduals with extensive lesion (lesion involvement exceeding 50% or theaggregate diameter of all cavities exceeding 6 cm) ;
- Individuals will be excluded from enrollment if, at the time of enrollment, theirM. tuberculosis isolate is already known to be resistant to any one or more of thefollowing: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones;
- Individuals with impaired liver function (alanine transaminase [ALT] or totalbilirubin [TBIL] more than 2.5 times the upper limit of normal) or combined withliver cirrhosis;
- Hemoglobin is less than 70g/L, or platelet is less than 50*10^9/L;
- Estimated Glomerular Filtration Rate (eGFR) is less than 30 mL/min/1.73m2;
- Known allergic or intolerant to any of the study drugs;
- Pregnant or breast-feeding;
- Prior anti-TB treatment for more than one week in the past six months;
10.Known history of epilepsy, uncontrolled diabetes;
11.For HIV-positive subjects, T-lymphocyte (CD4 cell) counts less than 100cells/mm3;
- Unable to tolerant oral treatment.
Study Design
Study Description
Connect with a study center
Beijing Chest Hospital, Capital Medical University
Beijing 1816670, Beijing Municipality 2038349 200040
ChinaActive - Recruiting
Liupanshui City Third People's Hospital
Liupanshui 8533133, Guizhou 1809445
ChinaActive - Recruiting
Nayong County People's Hospital
Nayong 1799501, Guizhou 1809445 200040
ChinaActive - Recruiting
Huashan Hospital of Fudan University
Shanghai, Shanghai 200040
ChinaSite Not Available
Huashan Hospital of Fudan University
Shanghai 1796236, Shanghai Municipality 1796231 200040
ChinaSite Not Available
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang
ChinaSite Not Available
The First People's Hospital of Linping District, Hangzhou
Hangzhou 1808926, Zhejiang 1784764
ChinaActive - Recruiting

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