Table 4. WHO-defined 2003 endpoints for assessing antimalarial therapy: ACPR and ACPRp.
Treatment response, n/N (%) at: | PP population | ITT population | ||
CDA (N = 796)* | AL (N = 400)* | CDA (N = 914) | AL (N = 458) | |
Day 28 | ||||
Early treatment failure** | 8/760 (1) | 6/381 (2) | 65 (7) | 37 (8) |
Late clinical failure | 41 (5) | 16 (4) | 40 (4) | 17 (4) |
Late parasitological failure | 112 (14) | 44 (11) | 122 (13) | 49 (11) |
ACPR | 604/765 (79) | 315/381 (83) | 687 (75) | 355 (78) |
ACPRp† | 708/765 (93) | 360/381 (94) | 791 (87) | 403 (88) |
Day 42 | ||||
Late clinical failure | 69 (9) | 28 (7) | 66 (7) | 28 (6) |
Late parasitological failure | 167 (21) | 75 (19) | 179 (20) | 82 (18) |
ACPR | 527/771 (68) | 275/384 (72) | 604 (66) | 311 (68) |
ACPRp† | 697/771 (90) | 358/384 (93) | 774 (85) | 398 (87) |
For the PP population, patients with missing data or indeterminate results were excluded − the denominator shows the number of evaluable patients. For the ITT population, patients with missing or indeterminate PCR results were treated as failures. For ACPRp, in the PP and ITT analysis, patients with new infections were considered successes at that time point. However, at subsequent time points, the PP analyses considered these patients as missing and the ITT analysis assumed that they were failures.
Early treatment failure is the same for Day 42.
ACPRp is ACPR corrected using PCR genotyping for reinfection. Reinfection rate = ACPRp − ACPR.