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Table 4 Outcome measures used in a high-transmission area

From: A “reverse pharmacology” approach for developing an anti-malarial phytomedicine

Study Primary Outcome Secondary outcomes
Observational study: Dose-escalating clinical trial % of patients with Adequate Clinical Response at d14 in each dosage group (= dose response) % of patients with Adequate Clinical Response at d28
% of patients with total parasite clearance at days 14 and 28
% of patients experiencing adverse effects
Experimental study: Pragmatic Randomized Controlled Trial ‘clinical recovery’ at day 28 without need for re-treatment with the second-line anti-malarial Axillary temperature <37.5’C at day 14
Age-specific incidence of severe malaria days 0-28 (patients aged <5 years)
incidence of new clinical episodes of malaria d15-28
Mean haematocrit at day 28
% of patients experiencing adverse events