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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02042261

Enrollment

Registered

2014-01-22

Start date

2012-01-31

Completion date

2016-03-31

Last updated

2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Tuberculosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Age\>18 years, culture verified tuberculosis

Exclusion criteria

Other infectious diseases other than HIV or tuberculosis

Design outcomes

Primary

Measure	Time frame
Rifampicin concentration in relationship to MIC over 10	2 weeks

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results