Active Tuberculosis Clinical Trial
Official title:
The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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