In vivo efficacy of artemether-lumefantrine and artesunate-amodiaquine for uncomplicated Plasmodium falciparum malaria in Malawi, 2014

Table 4 Response to treatment over 28-day follow-up among participants with enrollment parasitemia <200,000 parasites/μL in a therapeutic efficacy study in Machinga, Nkhotakota, and Karonga Districts in Malawi, 2014 (n = 426)

Estimate	AL				ASAQ
	Total (n = 321)	Site			Total (n = 105)
	Total (n = 321)	Machinga (n = 112)	Nkhotakota (n = 104)	Karonga (n = 105)	Total (n = 105)
Participants lost to follow-up, n (%)	33 (10.3)	14 (12.5)	14 (13.5)	5 (4.8)	15 (14.3)
Treatment failure, n (%)
Early	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Late*	70 (24.3)	22 (22.5)	30 (33.3)	18 (18)	2 (2.2)
Day of failure, median (range)	21 (14, 28)	24.5 (14, 28)	21 (14, 28)	21 (14, 28)	17.5 (14, 21)
Reinfection*	68 (23.6)	22 (22.5)	30 (33.3)	16 (16)	1 (1.1)
Recrudescence	2 (0.7)	0 (0)	0 (0)	2 (2)	1 (1.1)
Day 3 clearance, % (95 % CI)^a	99.7 (97.5–100)	99.1 (94.5–100)	100 (96.5–100)	100 (96.6–100)	100 (96.6–100)
ACPR, % (95 % CI)^b
Uncorrected	75.7 (70–80.5)	77.6 (68–83.4)	67.7 (56–76.3)	82 (73.1–89)	97.8 (92.2–99.7)
PCR-corrected	99.3 (97.5–99.9)	100 (96.3–100)	100 (96–100)	98 (93–100)	99 (94–100)
Kaplan–Meier survival rate on day 28, % (95 % CI)^c
Uncorrected	76.3 (71.4–81.2)	78.2 (70.2–86.3)	67.4 (58–77.1)	82.2 (74.8–89.7)	97.9 (95–100)
PCR-corrected	99.3 (98.3–100)	100^d	100^d	97.9 (94.9–100)	99.0 (96.9–100)

* Significant difference between study sites (p < 0.05)
^aPercent day 3 clearance was estimated only among participants still enrolled in the study on day 3
^bAdequate clinical and parasitologic response (ACPR) was estimated only among participants who reached a valid study endpoint
^cThe Kaplan–Meier cumulative survival rate estimate included all study participants who contributed person-days during the 28-day follow-up
^dFor Kaplan–Meier cumulative survival rates of 100 %, confidence intervals were not estimated

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