Table 3 Uncorrected and PCR-corrected efficacy estimates, Burkina Faso therapeutic efficacy study, 2017–2018
Niangoloko | Nanoro | Gourcy | |||||||
|---|---|---|---|---|---|---|---|---|---|
AL | DP | DP | AL | DP | DP | AL | DP | DP | |
28 Days | 28 Days | 42 Days | 28 Days | 28 Days | 42 Days | 28 Days | 28 Days | 42 Days | |
Enrolled | 120 | 120 | 120 | 120 | 120 | 120 | 120 | 120 | 120 |
Reached study outcome (%) | 109 (90.8) | 113 (94.2) | 112 (93.3) | 114 (95.0) | 113 (94.2) | 112 (93.3) | 110 (91.7) | 113 (94.2) | 113 (94.2) |
Day 3 parasitaemia (%) | 2 (2.0) | 0 (0.0) | 0 (0.0) | 1 (0.9) | 2 (1.8) | 2 (1.8) | 0 (0.0) | 4 (3.5) | 0 (0.0) |
Early treatment failure (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.9) | 2 (1.8) | 2 (1.8) | 0 (0.0) | 4 (3.5) | 4 (3.5) |
Late clinical failure (%) | 13 (11.9) | 2 (1.7) | 4 (3.6) | 35 (30.7) | 2 (1.8) | 16 (14.3) | 25 (22.7) | 2 (1.8) | 11 (9.7) |
Late parasitological failure (%) | 25 (22.9) | 1 (0.9) | 9 (8.0) | 47 (41.2) | 6 (5.3) | 22 (19.6) | 32 (29.1) | 3 (2.7) | 20 (17.7) |
Recrudescence | 8 | 1 | 3 | 22 | 3 | 9 | 24 | 3 | 14 |
Reinfection | 23 | 2 | 7 | 55 | 6 | 24 | 29 | 2 | 17 |
No PCR result available | 7 | 0 | 3 | 5 | 1 | 5 | 4 | 0 | 0 |
ACPR | 71 | 111 | 99 | 31 | 103 | 72 | 53 | 104 | 78 |
% ACPR Uncorrected (95% CI) | 65.1 (55.4–74.0) | 98.2 (93.8–99.8) | 88,4 (80.0–93.7) | 27.2 (19.3–36.3) | 91.2 (84.3–95.7) | 64.3% (54.7–73.1) | 48.2 (38.6–57.9) | 92.0 (85.4–96.3) | 69.0 (59.6–77.4) |
% ACPR PCR-Corrected (95% CI) | 89.9 (81.0–95.5) | 99.1 (95.1–100) | 97.1 (91.6, 99.4 | 57.4 (43.2–70.8) | 97.2 (92.0–99.4) | 86.7 (77.5–93.2 | 68.8 (57.3–78.9) | 93.7 (87.4.-97.4) | 81.3 (72.0–88.5) |
Kaplan–Meier cumulative Efficacy | |||||||||
Uncorrected (95% CI) | 65.5 (55.8–73.6) | 98.2 (93.1–99.6) | 88.5 (88.1–93.2) | 27.8 (19.9–36.2) | 91.2 (84.2–95.1) | 64.3 (54.7–72.4) | 48.7 (39.1–57.6) | 92.0 (85.1–95.7) | 69.1 (59.7–76.7) |
PCR-corrected (95% CI) | 91.6 (83.9–95.7) | 99.1 (93.9–99.9) | 97.2 (91.7–99.1) | 74.4 (63.5–82.5) | 97.3 (92.0–99.1) | 88.7 (80.5, 93.6) | 75.6 (65.8–83.0) | 93.9 (87.6–97.0) | 83.6 (75.2–89.3) |