NCT02042261

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: Thomas Schon · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-11-01
• Completion: 2016-03-01
• First posted: 2014-01-22
• Last updated: 2016-03-03

Locations

2 sites across 1 country: Sweden