Table 1.
Summary of outcome measures
| Outcome measure | Description | |
|---|---|---|
| Efficacy | ||
| Primary | Mean number of days to gametocyte clearance (GCT) | Mean number of days per treatment arm for gametocytes to become undetectable using submicroscopic molecular testing methods (QT-NASBA). Reappearance of gametocytes after day 14 will be considered as re-infection and excluded |
| Secondary | Mean (±SD) area under the curve of gametocyte density per day during 14 days of follow-up | Total number of gametocytes (measured by QT-NASBA) seen over follow-up, averaged per day of follow-up (days 0–14) |
| Density of gametocytes on days 7, 10 and 14 | Mean number of gametocytes (measured by QT-NASBA) per treatment arm on days 7, 10 and 14 | |
| Proportion (%) of participants with gametocytes on each day of follow-up | For each treatment arm, percentage of participants with gametocytes (measured by QT-NASBA) on each day of follow-up from days 0–14 | |
| Safety | ||
| Primary | Mean (± SD) maximal fall (±) in Hb (haemoglobin, g/dl) from enrolment to day 28 of follow-up | Mean maximal greatest negative difference in Hb (measured by HemoCue) from enrolment value per treatment arm over 28 days follow-up |
| Secondary | Follow-up day of Hb nadir | Mean day of follow-up (day 0–28) per treatment arm of lowest Hb measurement (by HemoCue) |
| Maximal percentage fall in Hb level compared to enrolment value | Size of maximal Hb drop (by HemoCue) during follow-up (day 0–28) from enrolment value, divided by enrolment value, *100 | |
| Percentage of participants with Hb<5 g/dl during follow-up | Percentage (number) per treatment arm during days 0–28 | |
| Requirement for blood transfusion | Percentage (number) of children receiving blood transfusion per treatment arm during days 0–28 | |
| Evidence of black urine | Percentage (number) of children with documented black/dark urine with urine dipstick positive for Hb per treatment arm during days 0–28 | |
| Incidence of serious adverse events by sign, symptom, laboratory parameter and relationship to taking study drug | Percentage (number) per treatment arm during days 0–28 | |
| Incidence of gastrointestinal symptoms after taking study drug | Percentage (number) per treatment arm during days 2–7 | |
GCT, gametocyte clearance time; Hb, haemoglobin; QT-NASBA, quantitative real-time nucleic acid sequence-based analysis.