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

NCT02042261 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2016-03-03

No results posted yet for this study

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.

Conditions

  • Active Tuberculosis

Sponsors & Collaborators

  • University Hospital, Linkoeping

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Thomas Schon

    lead OTHER_GOV

Principal Investigators

  • Katarina Niward, MD · Linkoeping University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-11-30
Completion
2016-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02042261 on ClinicalTrials.gov