Lumefantrine in Venous Plasma Versus Dried Capillary Blood Spot
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
Measurement of the concentration of antimalarials in the blood of the general population
helps estimating the overall drug pressure and is used in efficacy studies. The current
sampling standard for drug measurement is plasma obtained by venous puncture. The use of a
Dried Blood Spots (DBS) sampling strategy can make some aspects of field trials conditions
easier, but concordance with usual venous sampling is not yet established.
The current work will allow validating the concentrations of lumefantrine measured in the DBS
samples collected during the field trials and validate the use of DBS for future studies. In
addition, bearing in mind the substantial deployment of artemether-lumefantrine combinations
supplies throughout most malaria endemic countries, this study may improve our understanding
of lumefantrine and artemether distribution in the blood compartments and generate knowledge
for further developing analytical methods for drug measurement.
The overall purpose of this study is to validate the dried blood spots as a sampling method
for the analysis of lumefantrine.
The primary objective is to assess the concordance between lumefantrine plasma and dried
blood spots (DBS) concentrations.
The investigators also aim at describing lumefantrine's distribution in the different blood
compartments: binding to plasma proteins, total in plasma, inside the red blood cells, total
in whole blood.
Phase:
Phase 4
Details
Lead Sponsor:
Thierry Buclin
Treatments:
Artemether Artemether-lumefantrine combination Artemether, Lumefantrine Drug Combination Artemisinins Lumefantrine