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

Active Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042261
• Other study ID #: TB-TDM
• 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

• Active Tuberculosis
• Tuberculosis

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