Possible outcomes | Description |
---|---|
Recrudescence of P. falciparum | Recurrent infection caused by the parasites that survived treatment. This is the primary endpoint in antimalarial efficacy studies of uncomplicated P. falciparum malaria |
Novel infections due to P. falciparum or P. vivax | Recurrent infection due to a new parasite strain or strains during the follow-up. This can be due to a different Plasmodium species or due to the same species but different genotype from the initial parasite infection |
Indeterminate recurrent infection | Recurrent infection with the same parasite species but in which molecular analysis is unable to discriminate between a recrudescent or new infection (e.g. due to unsuccessful amplification of DNA). These patients are usually excluded when deriving efficacy estimates |
Patients in whom follow-up is curtailed before the end of the study or the occurrence of the primary event | Incomplete follow-up can occur in patients who fail to return to the clinic for follow-up, withdraw their consent or other reasons for discontinuation. These patients are censored in K–M survival analysis and excluded from per protocol analysis |
Adequate clinical and parasitological response (ACPR) | Treatment success, defined as the absence of parasitaemia at the end of the study follow-up |