Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated falciparum Malaria

Antimalarial drug resistance has emerged as a leading threat to ongoing malaria control efforts. As resistance to one or more antimalarial drugs occurs more frequently, malaria control programmes and other concerned institutions need to be able to evaluate antimalarial drug efficacy in a way that provides timely, relevant, reliable, and understandable information.

Related Link: :: Generic Protocols and Flow Diagram for in vivo Antimalarial Drug-Efficacy Studies in the Americas.  (In Spanish)

Data derived from these evaluations are essential not only for maintaining confidence that current treatment recommendations are adequate in relation to malaria patients' needs, but also, should that not be the case, for generating convincing evidence that current treatment recommendations are in need of change. When such evaluations are conducted consistently over time and in a reasonable and representative selection of sites, programmes should be able to monitor drug efficacy in a way that will allow changes in treatment recommendations or policies to be made early enough to minimize the impact of a failing treatment regimen.

The primary goal of this protocol is to provide guidance in obtaining the minimum essential information about the clinical and parasitological response to antimalarial drugs among populations at greatest risk of severe morbidity or mortality due to malaria. The intended use of this protocol, therefore, is primarily as a tool for the collection of clinically relevant information for developing evidence-based antimalarial treatment policy. It is not intended for use as a more traditional biomedical research protocol and is not intended to replace welldesigned clinical trials conducted under Good Clinical Practice (GCP) guidelines, as should be done when investigating new treatment lacking an adequate history of safe clinical use.

Considerable emphasis has been placed on maintaining as much simplicity and practicality as possible. Using this protocol, programmes lacking access to substantial financial resources or to state-of-the-art laboratory analysis—most often obtained through collaborative links with medical research institutions-should nonetheless be able to produce the information needed to ensure the best malaria treatment for the people living in their country. Programmes that do have adequate resources and expertise are encouraged to collect any additional information that they feel is relevant. However, they are also encouraged to at least collect this minimal data set in a way that is consistent with this protocol. Only through such standardization will it be possible to compare and interpret results over time and within or between regions.