Latent tuberculosis infection during hemodialysis
Conditions
Interventions
Experimental Group (Optimized 3HP:Reduced-dose 3HP (Isoniazid 900mg/week + Rifapentine 600mg/week)
Control group (Standard 3HP):Standard-dose 3HP (Isoniazid 900mg/week + Rifapentine 900mg/week)
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The patient's age is between 18 and 75 years old, with no gender restrictions. They voluntarily sign the informed consent form and can understand the research process and cooperate with the follow-up. 2. Clear diagnosis of LTBI, no active tuberculosis imaging manifestations on chest CT, positive Mycobacterium tuberculosis-specific interferon release test (IGRAs), or maximum diameter of tuberculin skin test (TST) >=10 mm; 3. Background in hemodialysis, having received maintenance hemodialysis for at least 3 months. At the same time, stabilize the dialysis plan without any major adjustments to the dialysis mode or dialysis prescription in the near future. 4. No obvious abnormalities were found in liver function. Peripheral blood examination did not indicate pancytopenia or other serious hematological abnormalities. 5. Understand and sign informed consent. During the research period, be able to take medicine, undergo tests and follow-up as prescribed, and report adverse reactions in a timely manner
Exclusion criteria
Exclusion criteria: 1.Those who are allergic to or intolerant to the preventive anti-tuberculosis drug regimens in the study; 2. Active tuberculosis or previous treatment history, such as clinically or radiologically confirmed active pulmonary tuberculosis or tuberculous pleurisy. Excluding those who have received 3HP or other LTBI preventive treatments and have failed the treatment; 3. Those who have participated in other clinical trials (in vivo trials) within the past three months; 4. Co-infection with nontuberculous mycobacteria; 5. Concurrent major diseases: Except for chronic renal insufficiency (i.e., caused by hemodialysis), participants have no severe organ dysfunction of the heart, liver, lungs, nervous system, or blood system, or have severe advanced malignant tumors, HIV infection, etc. 6. Special groups and others: Pregnant and lactating women, those who have participated in other interventional clinical trials within 6 months, those with mental or cognitive impairments who are unable to cooperate, and other conditions deemed unsuitable for continued participation by the researcher (such as extremely poor compliance, planning for kidney transplantation or transfer to another hospital).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Completion Rate;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of active tuberculosis during the follow-up period (within 2 years after the completion of preventive treatment); | — |
Countries
China
Contacts
Public ContactXia Lu
Shanghai Public Health Clinical Center
Outcome results
None listed