Personalization of AntiTB Treatment: Evaluation of Pharmacological Determinants of Treatment Response
NCT03416309 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 257
Last updated 2019-04-17
Summary
The aim of the study is to investigate the possible correlation of plasma drug concentrations with Time To Positivity (TTP) in liquid culture in patients with active pulmonary multi sensitive TB in the first two weeks of treatment. Secondary aims are: the correlation between plasma drug concentrations and hepato/neuro toxicity; the impact of different allelic variants on PK data, toxicity and TTP in liquid culture; the feasibility of using dried blood/plasma spots to measure plasma concentrations of anti-TB drugs and determine genetic polymorphisms.
Conditions
- Tuberculosis, Pulmonary
Sponsors & Collaborators
-
Research Center Borstel
collaborator OTHER -
University of Turin, Italy
lead OTHER
Principal Investigators
-
Ilaria Motta, MD · University of Turin, Italy
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-25
- Primary Completion
- 2021-02-28
- Completion
- 2022-02-28
Countries
- Italy
Study Locations
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