Active Tuberculosis Clinical Trial
Official title:
The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Sweden | Dept of Infectious Diseases | Linköping | |
Sweden | Dept of Infectious Diseases, TB-unit, Karolinska Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Thomas Schon | Karolinska University Hospital, University Hospital, Linkoeping |
Sweden,
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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