This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).
Patients receive MDR-TB treatment with o.a. Levofloxacin and Capreomycin. At least one week after start of treatment, the PK samples samples will be obtained via an intravenous catheter at 0, 1, 2, 3, 4, 7, and 12 hours after intake.
Study Type
OBSERVATIONAL
Enrollment
20
multiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters
Republican Scientific and Practical Center for TB and Pulmonology
Minsk, Belarus
AUC/MIC ratio of Levofloxacin
The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the area under the serum concentration-time curve (AUC) over 24 hours (AUC0-24h ), \[AUC0-24h /MIC\], after administration of Levofloxacin.
Time frame: after day 8 of treatment
Cmax/MIC ratio of Capreomycin
The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the maximum serum concentration, \[Cmax/MIC\], after administration of Capreomycin.
Time frame: after day 8 of treatment
Volume of Distribution
Based on the measured drug concentration during the dosing interval and patient characteristics (height, bodyweight and age) the volume of distribution will be calculated
Time frame: after day 8 of treatment
Clearance
Based on the drug concetrations during the dosing interval and patient characteristics (height, bodyweight, age) the drug clearance will be calculated
Time frame: after day 8 of treatment
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