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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02042261
Other study ID # TB-TDM
Secondary ID
Status Completed
Phase N/A
First received January 20, 2014
Last updated March 1, 2016
Start date January 2012
Est. completion date March 2016

Study information

Verified date March 2016
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date March 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Age>18 years, culture verified tuberculosis

Exclusion Criteria:

Other infectious diseases other than HIV or tuberculosis

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Dept of Infectious Diseases Linköping
Sweden Dept of Infectious Diseases, TB-unit, Karolinska Hospital Stockholm

Sponsors (3)

Lead Sponsor Collaborator
Thomas Schon Karolinska University Hospital, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rifampicin concentration in relationship to MIC over 10 2 weeks No
Secondary Cure rate on Clinical follow up (according to WHO criteria) in relation to rifampicin concentration at week 2 1 year No
Secondary Sputum Culture conversion in relation to rifampicin, isoniazid and pyrazinamid concentration week 2 2 and 8 weeks No
Secondary TB-score in relation to rifampicin, isoniazid and pyrazinamid concentration week 2 8 weeks No
Secondary Time to positive Culture (TTP) in relation to isoniazid, ethambutol and pyrazinamid serum concentration and minimal inhibitory concentration (MIC) 2 and 8 weeks No
Secondary Time to positive Culture (TTP) in relation to rifampicin serum concentration and minimal inhibitory concentration (MIC) 2weeks No
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