Status:
ACTIVE_NOT_RECRUITING
Subclinical TB With Innovative Modified Short-course Regimens
Lead Sponsor:
Huashan Hospital
Conditions:
Tuberculosis
Eligibility:
All Genders
14-80 years
Phase:
PHASE4
Brief 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 changi...
Detailed Description
This study is a prospective, open-label, multicenter randomized controlled trial. The randomization process employs central stratified block randomization to balance biases across different centers, i...
Eligibility Criteria
Inclusion
- 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
- 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
- Have optic neuritis, alcoholism, epilepsy, mental illness, diabetes mellitus with fundus lesions, porphyria, myasthenia gravis
- Pregnant or breast-feeding.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT06153069
Start Date
November 1 2023
End Date
November 1 2027
Last Update
December 14 2023
Active Locations (2)
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1
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200040
2
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang, China