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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)

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

Estimate

AL

ASAQ

Total (n = 321)

Site

Total (n = 105)

Machinga (n = 112)

Nkhotakota (n = 104)

Karonga (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)

100d

100d

97.9 (94.9–100)

99.0 (96.9–100)

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