The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study
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.
Inclusion Criteria:

 Age>18 years, culture verified tuberculosis

 Exclusion Criteria:

 Other infectious diseases other than HIV or tuberculosis