Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Other

If ‘other’, further details on the scope of the study

Characterisation of proteomic profiles
Non-interventional study

Non-interventional study design

Case-control
Study drug and medical condition

Medical condition to be studied

Hepatotoxicity
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

500
Study design details

Main study objective

Characterisation of proteomic profiles

Outcomes

The main goal is the identification and characterisation of biological markers which would be predictive of hepatotoxicity associated with anti-tuberculous drugs. To determine plasma protein levels before the treatment, at 21 days after initiation the treatment and at the end of the treatment.

Data analysis plan

Data analysis plan- Cox regression model for Hazard rate estimation.- Close monitoring of included and excluded patients in each participating centre.- Use of structured questionnaire for retrieval of drug use.- Use of Cox regression model for risk and confounding factors.- Inclusion of centers with the highest follow-up rate of tuberculosis in Barcelona area.