Study on short course treatment regimens for tuberculosis infection containing isoniazid and rifapentine: A multi-arm, multi-stage, adaptive, multi-centre, randomized, controlled, open-label, non-inferiority trial

Phase 4

Conditions: Tuberculosis infection

Registration Number: ChiCTR2400089027

Lead Sponsor: The Third People's Hospital of Shenzhen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(1) Age =2 years, male or non pregnant, non- lactating female. (2) There is no evidence of active tuberculosis on chest X-ray or chest CT. (3) One of the following groups of people who meet the recommendations for preventive treatment of tuberculosis in the 2020 Edition of WHO Comprehensive Guidelines for Tuberculosis: Module 1 or the China Technical Code for Tuberculosis Preventive and Control Work (2020 Edition): (i) Children aged 2-5 years who are in close contact with pathogenic positive pulmonary tuberculosis patients, regardless of whether the results of tuberculosis immunology test are positive. (ii) People =5 years old who have close contact with pulmonary tuberculosis patients, and whose tuberculosis immunological test results are positive. (4) For those =7 years of age, parents or guardians agreed and signed the informed consent form on their behalf; for those 8-17 years of age, parents or guardians agreed and co-signed the informed consent form; and for those =18 years of age, they participated voluntarily and signed the informed consent form. (5) No pregnancy plans during the period of receiving preventive drug treatment and within six months after discontinuation of drug.

Exclusion Criteria

(1) Pathogenic or clinically diagnosed tuberculosis. (2) Suspected tuberculosis. (3) History of exposure to drug-resistant TB cases prior to enrolment. (4) History of treatment with isoniazid for =30 consecutive days or rifamycin antibiotics for =14 consecutive days within 2 years prior to enrolment. (5) Allergy or intolerance to the study drug or its formulation components. (6) Drugs that have significant interactions with the study drug are being used. (7) Alcohol dependents. (8) Serum alanine aminotransferase or aspartate aminotransferase > 3 times the upper limit of normal, total bilirubin > 2.5 times the upper limit of normal, history of cirrhosis, viral hepatitis undergoing antiviral treatment, and suspicious manifestations of acute hepatitis within 90 days prior to enrollment, such as abdominal pain, jaundice, vomiting, etc. (9) Severe haematological disorders: absolute neutrophil count <0.75 x 10^9/L, platelet count <50 x 10^9/L, haemoglobin <70 x 10^9/L. (10) According to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, peripheral neuropathy is = grade 2. (11) Weight < 10.0kg. (12) HIV-infected persons.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of adverse events at all levels;Cumulative incidence rate of tuberculosis;Incidence density of tuberculosis;Treatment completion rate;

Secondary Outcome Measures

Name	Time	Method
Incidence rate of serious adverse events;Incidence rate of grade 3-4 adverse events associated with anti-tuberculosis drugs;Discontinuation rate due to adverse drug reactions;Overall mortality rate;Non tuberculosis mortality rate;