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 |