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The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study

Sponsor
Thomas Schon (Other)
Overall Status
Completed
CT.gov ID
NCT02042261
Collaborator
University Hospital, Linkoeping (Other), Karolinska University Hospital (Other)
38
Enrollment
2
Locations
50
Duration (Months)
19
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Drug resistant TB is increasing and in order to enchance the efficacy of the current drugs, individualized therapy using plasma drug concentrations and minimal inhibitory concentration (MIC) determination may be of importance. This concept is defined as therapeutic drug monitoring (TDM).

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    38 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study
    Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    Nov 1, 2015
    Actual Study Completion Date :
    Mar 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Rifampicin concentration in relationship to MIC over 10 [2 weeks]

    Secondary Outcome Measures

    1. Cure rate on Clinical follow up (according to WHO criteria) in relation to rifampicin concentration at week 2 [1 year]

    2. Sputum Culture conversion in relation to rifampicin, isoniazid and pyrazinamid concentration week 2 [2 and 8 weeks]

    3. TB-score in relation to rifampicin, isoniazid and pyrazinamid concentration week 2 [8 weeks]

    4. Time to positive Culture (TTP) in relation to isoniazid, ethambutol and pyrazinamid serum concentration and minimal inhibitory concentration (MIC) [2 and 8 weeks]

    5. Time to positive Culture (TTP) in relation to rifampicin serum concentration and minimal inhibitory concentration (MIC) [2weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Age>18 years, culture verified tuberculosis

    Exclusion Criteria:

    Other infectious diseases other than HIV or tuberculosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept of Infectious Diseases Linköping Sweden 581 85
    2 Dept of Infectious Diseases, TB-unit, Karolinska Hospital Stockholm Sweden 17671

    Sponsors and Collaborators

    • Thomas Schon
    • University Hospital, Linkoeping
    • Karolinska University Hospital

    Investigators

    • Principal Investigator: Katarina Niward, MD, Linkoeping University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Schon, MD PhD, Linkoeping University
    ClinicalTrials.gov Identifier:
    NCT02042261
    Other Study ID Numbers:
    • TB-TDM
    First Posted:
    Jan 22, 2014
    Last Update Posted:
    Mar 3, 2016
    Last Verified:
    Mar 1, 2016
    Additional relevant MeSH terms:
    Tuberculosis

    Study Results

    No Results Posted as of Mar 3, 2016