Clinical trial

Clinical Efficacy of a Short-course Regimen for Subclinical Tuberculosis in China

Name

KY2023-715

Description

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.

Trial arms

Trial start

2023-11-01

Estimated PCD

2025-10-01

Trial end

2027-11-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Short-course regimen

During the intensive phase (8 weeks), rifampicin ≤50kg 450 mg daily, \>50kg 600 mg daily; isoniazid 300 mg daily; pyrazinamide ≤50kg 1000mg daily, 50-70kg 1500mg daily, \>70kg 2000mg daily; ethambutol ≤50kg 750mg daily, \>50kg 1000mg daily; All treatment is taken orally. During the continuation phase (0 or 9 weeks based on the radiological manifestations), rifampicin ≤50kg 450 mg daily, \>50kg 600 mg daily; isoniazid 300 mg daily; All treatment is taken orally.

Arms:

Short-Course Regimen

Standard regimen

During the intensive phase (8 weeks), rifampicin ≤50kg 450 mg daily, \>50kg 600 mg daily; isoniazid 300 mg daily; pyrazinamide ≤50kg 1000mg daily, 50-70kg 1500mg daily, \>70kg 2000mg daily; ethambutol ≤50kg 750mg daily, \>50kg 1000mg daily; All treatment is taken orally. During the continuation phase (18 weeks), rifampicin ≤50kg 450 mg daily, \>50kg 600 mg daily; isoniazid 300 mg daily; All treatment is taken orally.

Arms:

Standardized Regimen

Size

556

Primary endpoint

Treatment success rate of the short-course regimen

78 weeks after treatment initiation

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 556, 'type': 'ESTIMATED'}}

Updated at

2023-12-14

1 organization

2 products

1 indication

Organization

Product

Indication

Product