Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients
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|ClinicalTrials.gov Identifier: NCT02169141|
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Pharmacokinetics of Levofloxacin and Capreomycin in MDR-TB Patients|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||November 2013|
PK of Levofloxacin-Capreomycin
Pharmacokinetics (PK) in M/XDR-TB patients receiving at least Levofloxacin and Capreomycin as part of their WHO treatment for M/XDR-TB
multiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters
- AUC/MIC ratio of Levofloxacin [ Time Frame: after day 8 of treatment ]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.
- Cmax/MIC ratio of Capreomycin [ Time Frame: after day 8 of treatment ]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.
- Volume of Distribution [ Time Frame: after day 8 of treatment ]Based on the measured drug concentration during the dosing interval and patient characteristics (height, bodyweight and age) the volume of distribution will be calculated
- Clearance [ Time Frame: after day 8 of treatment ]Based on the drug concetrations during the dosing interval and patient characteristics (height, bodyweight, age) the drug clearance will be calculated
- PK-model [ Time Frame: after day 8 of treatment ]A population PK model will be developed using an iterative 2-stage Bayesian procedure.
- Limited sampling strategy [ Time Frame: after day 8 of treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169141
|Republican Scientific and Practical Center for TB and Pulmonology|
|Minsk, Belarus, 220053|
|Principal Investigator:||JW C Alffenaar, PhD PharmD||UMCG|