TABLE 2.
Trial outcomes over 28 days of follow-up and prevalence of parasitemia, anemia, and thrombocytopenia at selected time pointsa
| Outcome | No. of individuals tested | Value for treatment regimen |
P valueb | |
|---|---|---|---|---|
| Sequential CQ-PQ (arm 1) | Concomitant CQ-PQ (arm 2) | |||
| ACPR rate (%) over 28 days (95% CI) | 174 | 97.8 (91.4–99.6) (n = 90) | 100.0 (94.5–100.0) (n = 84) | 0.498c |
| Mean parasite clearance time (days) (95% CI) | 188 | 2.54 (1.73–3.35) (n = 96) | 1.89 (1.71–2.05) (n = 92) | 0.482d |
| Mean parasite DNA clearance time (days) (95% CI) | 176 | 3.26 (2.84–3.69) (n = 88) | 2.77 (2.41–3.13) (n = 88) | 0.063d |
| Mean fever clearance time (days) (95% CI) | 179 | 1.51 (1.39–1.62) (n = 91) | 1.78 (1.47–2.07) (n = 88) | 0.086d |
| No. (%) of subjects with asexual parasite prevalence detected by microscopy | ||||
| Day 1 | 182 | 62 (66.7) (n = 93) | 61 (68.5) (n = 89) | 0.874c |
| Day 2 | 180 | 13 (14.3) (n = 91) | 13 (14.6) (n = 89) | 1.000c |
| Day 3 | 180 | 3 (3.4) (n = 92) | 1 (1.1) (n = 88) | 0.621c |
| No. (%) of subjects with parasite DNA carriage determined by PCR | ||||
| Day 1 | 182 | 84 (90.3) (n = 93) | 78 (87.6) (n = 89) | 0.639c |
| Day 2 | 181 | 52 (56.5) (n = 92) | 33 (37.1) (n = 89) | 0.011c |
| Day 3 | 178 | 20 (21.7) (n = 92) | 11 (12.8) (n = 86) | 0.166c |
| Day 28 | 173 | 7 (7.9) (n = 89) | 1 (1.1) (n = 84) | 0.065c |
| No. (%) of subjects with gametocyte-specific transcript carriage on day 3 | 167 | 19 (11.5) (n = 87) | 3 (3.8) (n = 80) | 0.088c |
| No. (%) of subjects with anemia | ||||
| Day 1 | 181 | 43 (46.2) (n = 93) | 43 (48.9) (n = 88) | 0.767c |
| Day 2 | 181 | 46 (50.0) (n = 92) | 45 (50.6) (n = 89) | 1.000c |
| Day 3 | 180 | 37 (40.2) (n = 92) | 44 (50.0) (n = 88) | 0.231c |
| Day 7 | 166 | 34 (37.0) (n = 92) | 28 (37.8) (n = 74) | 1.000c |
| Day 28 | 163 | 24 (27.6) (n = 87) | 28 (36.8) (n = 76) | 0.240c |
| No. (%) of subjects with thrombocytopenia on day 28 | 156 | 9 (13.2) (n = 68) | 5 (7.7) (n = 65) | 0.340c |
a
ACPR, adequate clinical and parasitological response, defined as the absence of asexual blood-stage parasites detected by microscopy by day 28, regardless of axillary temperature, with no evidence of earlier treatment failure.
b
Statistical comparisons of response rates, clearance times, and prevalences are presented for exploratory purposes, but this study was not originally designed and powered to detect significant differences between arms.
c
By Fisher’s exact test.
d
By a Mantel-Cox log rank test.