An observational study in Tuberculosis, sponsored by University Medical Center Groningen. Completed at 1 site in Belarus. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-23.
Sponsored by University Medical Center Groningen · Observational
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 20 is below the median of 250 across 421 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
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MDR-TB patients
Exclusion Criteria:
Pharmacokinetics (PK) in M/XDR-TB patients receiving at least Levofloxacin and Capreomycin as part of their WHO treatment for M/XDR-TB
Other: Pharmacokinetics
multiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters
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
PK-model
A population PK model will be developed using an iterative 2-stage Bayesian procedure.
Time frame: after day 8 of treatment
Limited sampling strategy
Limited sampling strategies were investigated subsequently using a Bayesian analysis. The best possible strategies for will be evaluated by a Bland-Altman analysis for correlation of predicted and observed AUC0-24.
Time frame: after day 8 of treatment
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen