Latent tuberculosis infection (LTBI)
Conditions
Interventions
1HP prophylactic anti-tuberculosis treatment group:Isoniazid and rifapentin combined with prophylactic anti-tuberculosis therapy for 28 days
Sponsors
The Third People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
No minimum to 14 Years
Inclusion criteria
Inclusion criteria: 1.Participants were <=14 years old; 2.Identified as close contacts of patients with drug-susceptible tuberculosis infection.(Close contacts are defined as those who had direct contact with a bacillus-positive TB patient between 3 months before diagnosis and 2 weeks after initiation of anti-tuberculosis treatment, and can be divided into intra-household close contacts (including people living in the same household or frequent visitors to the home) and extra-household close contacts (including work colleagues, schoolmates, etc.); 3.Indications for prophylaxis of LTBI in children: a.Children in close contact with a patient with positive etiologies for tuberculosis: under 5 years old from an area with a high incidence of tuberculosis; Children over 5 years of old from areas with a low incidence of tuberculosis; b.Children in close contact with patients with aetiologically negative pulmonary tuberculosis:If IGRA or TST is positive, prophylactic treatment is recommended for people under 5 years of age, and prophylactic treatment is voluntary for people over 5 years old; c.Immunosuppressed children:Children with immunodeficiency diseases, autoimmune diseases, hematologic diseases, malnutrition, early malignant tumors, long-term use of glucocorticoids and biological agents, organ or bone marrow transplantation, and hemodialysis should be given preventive treatment if LTBI is clearly present; d.Students with a history of close contact in the school are clearly LTBI patients, and preventive treatment is carried out on a voluntary basis with the informed consent of students and parents; e.LTBI prophylaxis is recommended in HIV-positive children and adolescents, regardless of exposure to active TB and excluding active TB; 4.With the consent of the subject's parents or guardians, the subject received 1HP prophylactic anti-tuberculosis therapy, and could comply with the requirements of the clinical research protocol, participate in the whole follow-up visit, and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with suspected or confirmed active tuberculosis or recent tuberculosis medication based on clinical evaluation; 2.Patients exposed to isoniazid and/or rifampicin-resistant tuberculosis; 3.Patients with allergies and intolerances to isoniazid, rifampicin, or rifapentin; 4.Receiving drugs that have significant interactions with isoniazid, rifampicin, or rifapentin; 5.Participated in other clinical trials in the past three months; 6.Those who have any of the following conditions are not suitable for preventive treatment: a.Those who are receiving treatment for active viral hepatitis or with more than 3-fold elevation of transaminases; b.People with allergies, or those whose bodies are in the allergic stage; c.Patients with a history of previous psychiatric illness and epilepsy, or those receiving antipsychotic medication; d.Patients with blood system diseases, platelet count < 50*10^9/L, white blood cell count <3000*10^9/L; e.Children with severe immunosuppression, advanced malignancy, and after organ or bone marrow transplantation; f.Those who are known to have poor compliance before taking the drug and cannot adhere to the prescribed course of treatment; g.Those who have previously suffered from tuberculosis and completed standard anti-tuberculosis treatment within 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of anti-tuberculosis treatment with 1HP regimen; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions to isoniazid and rifapentin;Calculate the number of participants with preventive treatment interruptions and understand the proportional timeframe in relation to discontinuation of medication for any reason.;Blood routine;Routine liver function tests;Renal function tests;Lymphocyte tuberculosis immunoassay;Lymphocyte tuberculosis immunoassay;Concentration of rifapentine;Anterolateral radiographs of the chest; | — |
Countries
China
Contacts
Public ContactWeijian Liu
The Third People's Hospital of Shenzhen
Outcome results
None listed