Subclinical TB With Innovative Modified Short-course Regimens

• Status: Active, not recruiting
• Trial end date: 2027-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized controlled trial among subclinical tuberculosis patients aiming to assess whether the standard treatment duration can be shortened to 17 weeks or even 8 weeks without changing the current anti-tuberculosis drugs or dosages.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital

Criteria

Inclusion Criteria:

• 1. Age between 14 to 80 years;

• 2. Male or female;

• 3. Weight between 40 to 80 kg;

• 4. Willing to provide signed informed consent, or parental consent and participant assent.

• 5. Individuals with respiratory tract specimen (including sputum/induced sputum/bronchoalveolar lavage fluid/lung tissue) smear/culture/rapid molecular tests-positive pulmonary tuberculosis;

• 6. No tuberculosis related symptoms that could not be explained by other causes within 6 months before enrollment. Tuberculosis related symptoms includes cough for more than 2 weeks, expectoration, hemoptysis, fever, night sweats, and weight loss.

• 7. Not received any anti-TB treatment in the past 6 months

• 8. If non-menopausal woman, agree to use or have used effective contraception during treatment.

Exclusion Criteria:

• 1. Combined extrapulmonary tuberculosis;

• 2. Patients with extensive lesion (extent of disease greater than 50% or cavity size greater than 4cm) ;

• 3. Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones;

• 4. Patients with impaired liver function (alanine transaminase [ALT], alkaline phosphatase [ALP] or total bilirubin [TBIL] more than 2 times the upper limit of normal) or combined with liver cirrhosis;

• 5. Leucocyte is less than 3×10^9/L, or hemoglobin is less than 90g/L, or platelet is less than 100*10^9/L;

• 6. Estimated Glomerular Filtration Rate (eGFR) is less than 60 mL/min/1.73m2

• 7. Known allergic or intolerant to any of the study drugs

• 8. Can not take oral medications

• 9. HIV antibody positive and AIDS patients

• 10.Have optic neuritis, alcoholism, epilepsy, mental illness, diabetes mellitus with fundus lesions, porphyria, myasthenia gravis

• 11.Pregnant or breast-feeding.