Table 1.
Term | Related terms | Definition |
---|---|---|
TES | In vivo study, therapeutic efficacy trial, and antimalarial efficacy trial | Clinical outcome trial to assess antimalarial efficacy in patients with malaria |
Recurrent parasitemia | Late recurrence and late treatment failure* | Recurrence of microscopy-detectable parasitemia during follow-up despite initial clearance, typically defined as occurring 7 days or longer after initiation of therapy |
New infection | Reinfection | Recurrent parasitemia due to a new infection with a parasite strain/clone different from the strain/clone from the original infection |
Recrudescence | True treatment failure | Recurrent parasitemia due to inadequate clearance of a parasite strain/clone from the original infection |
Locus | Marker and gene | A polymorphic site or region in the parasite genome that can be used to differentiate between different parasite strains |
Allele | Band and haplotype | A distinct variant of a given locus; even though Plasmodium is haploid in the human host, multiple alleles can be observed in a given sample due to a multi-clone infection (concurrent infection by more than one strain) |
Molecular correction | PCR correction | Process by which cases of recurrent parasitemia are classified as new infections or recrudescences by comparison of parasite genotypes |
PCR-corrected efficacy | Corrected efficacy | Primary indicator from TESs, where only recrudescent infections are counted as treatment failures and reinfections are excluded or censored |
TESs = therapeutic efficacy studies.
“Recurrent parasitemia” and “late recurrence” are preferable terms to “late treatment failure” because they unambiguously encompass both recrudescences and new infections.