Status:
ACTIVE_NOT_RECRUITING
Analysis of Liver Injury Risk Factors in a Multiethnic Population Treated With Antituberculosis Drugs
Lead Sponsor:
Stefania Cheli
Conditions:
Tuberculosis Infection
Eligibility:
All Genders
18+ years
Brief Summary
Tuberculosis (TB) is the world's second leading cause of death from a single infectious agent after COVID-19. In 2022, TB was estimated to have affected 10.6 million people, of whom 1.3 million died b...
Detailed Description
Tuberculosis (TB) is the world's second leading cause of death from a single infectious agent in 2022, after COVID-19. In 2022, TB disease was estimated to affect 10.6 million people, of whom 1.3 mill...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- adult patients (\>18 years)
- patient who received standard initial therapy including INH (5mg/kg), RMP (10mg/kg), and PZA (25mg/kg) for patients with active TB disease
- treatment with first line anti-TB drugs, including rifampicin and isoniazid for patients with latent TBI
- normal serum ALT and bilirubin levels, no symptoms related to abnormal liver function prior to anti-TB drug treatment
- informed consent.
- Exclusion criteria:
- liver dysfunction, including biliary origin, before anti-TB therapy
- patients receiving non-standard treatment regimen initially (e.g., patients with severe pulmonary or extrapulmonary TB receiving large doses or more than four anti-TB drugs), 3) modified treatment regimen due to drug resistance or intolerance excluding first line anti-TB drugs
- 4\) lactation or pregnancy 5) concomitant use of hepatotoxic drugs 6) abnormal hepatic function on laboratory testing before anti-TB 7) disease that was resistant to INH at the start of treatment 8) patients refusing to sign informed consent.
Exclusion
Key Trial Info
Start Date :
July 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT06539455
Start Date
July 5 2024
End Date
September 30 2024
Last Update
August 6 2024
Active Locations (1)
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1
ASST Fatebenefratelli Sacco
Milan, Italy, 20157