The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study
NCT ID: NCT02042261
Last Updated: 2016-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
38 participants
OBSERVATIONAL
2012-01-31
2016-03-31
Brief Summary
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In this pilot study our hypothesis is that the ratio between MIC and drug concentration data is correlated to the bacterial load measured as time to positive liquid culture (TTP).
In two sites in Sweden (Linköping and Karolinska Hospital Solna, Stockholm), 25 patients with pulmonary tuberculosis will be recruited. MIC-determination of Mycobacterium tuberculosis will be performed in BACTEC 960 MGIT and drug concentration will be determined at 2, 4 and 12 weeks after treatment initiation using LC-MS/MS methodology. Sputum cultures will be obtained at 0, 2 days, 7 days, 2 weeks, 4 weeks and 8 weeks and TTP will be measured in duplicate samples. Clinical follow up according to WHO criteria will be performed 1 year after completion of treatment.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Linkoeping
OTHER
Karolinska University Hospital
OTHER
Thomas Schon
OTHER_GOV
Responsible Party
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Thomas Schon
MD PhD
Principal Investigators
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Katarina Niward, MD
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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Dept of Infectious Diseases
Linköping, Linköping, Sweden
Dept of Infectious Diseases, TB-unit, Karolinska Hospital
Stockholm, Stockholm County, Sweden
Countries
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References
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Niward K, Davies Forsman L, Bruchfeld J, Chryssanthou E, Carlstrom O, Alomari T, Carlsson B, Pohanka A, Mansjo M, Jonsson Nordvall M, Johansson AG, Eliasson E, Werngren J, Paues J, Simonsson USH, Schon T. Distribution of plasma concentrations of first-line anti-TB drugs and individual MICs: a prospective cohort study in a low endemic setting. J Antimicrob Chemother. 2018 Oct 1;73(10):2838-2845. doi: 10.1093/jac/dky268.
Other Identifiers
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TB-TDM
Identifier Type: -
Identifier Source: org_study_id
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