The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Active Tuberculosis
- Sponsor
- Thomas Schon
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Rifampicin concentration in relationship to MIC over 10
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Thomas Schon
MD PhD
Linkoeping University
Eligibility Criteria
Inclusion Criteria
- •Age\>18 years, culture verified tuberculosis
Exclusion Criteria
- •Other infectious diseases other than HIV or tuberculosis
Outcomes
Primary Outcomes
Rifampicin concentration in relationship to MIC over 10
Time Frame: 2 weeks
Secondary Outcomes
- Cure rate on Clinical follow up (according to WHO criteria) in relation to rifampicin concentration at week 2(1 year)
- Sputum Culture conversion in relation to rifampicin, isoniazid and pyrazinamid concentration week 2(2 and 8 weeks)
- TB-score in relation to rifampicin, isoniazid and pyrazinamid concentration week 2(8 weeks)
- Time to positive Culture (TTP) in relation to isoniazid, ethambutol and pyrazinamid serum concentration and minimal inhibitory concentration (MIC)(2 and 8 weeks)
- Time to positive Culture (TTP) in relation to rifampicin serum concentration and minimal inhibitory concentration (MIC)(2weeks)