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Table 4 ACPR (PCR-uncorrected) at Days 7, 14, 21, 28, 35, 42 (Cohort 2)

From: Comparison of azithromycin plus chloroquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children in Africa: a randomized, open-label study

Percentage of subjects with ACPR * (95% CI)

MITT population

PP population

AZCQ N = 120

AL N = 126

AZCQ N = 114

AL N = 124

Day 7

94.17 (89.55, 98.78)

99.21 (97.25, 100.00)

98.25 (95.39, 100.00)

100.00 (−,-)

ACPR % difference, 95% CI

-5.04 (-9.93, -0.15)

-1.75 (−.-)

Day 14

89.08 (83.05, 95.11)

96.79 (93.28, 100.00)

92.89 (87.69, 98.08)

97.56 (94.42, 100.00)

ACPR % difference, 95% CI

-7.71 (-14.54, -0.88)

-4.67 (-10.6, 1.25)

Day 21

67.87 (59.02, 76.72)

82.96 (75.91, 90.01)

70.56 (61.67, 79.45)

83.62 (76.65, 90.60)

ACPR % difference, 95% CI

-15.09 (-26.24, -3.94)

-13.07 (-24.21, -1.92)

Day 28

51.55 (42.07, 61.02)

73.31 (65.10, 81.52)

54.28 (44.57, 63.98)

73.90 (65.71, 82.08)

ACPR % difference, 95% CI

-21.79 (-34.14, -9.39)

-19.62 (-32.16, -7.08)

Day 35

44.67 (35.24, 54.11)

62.91 (54.00, 71.82)

47.04 (37.31, 56.77)

63.41 (54.49, 72.34)

ACPR % difference, 95% CI

-18.24 (-31.05, -5.43)

-16.38 (-29.42, -3.33)

Day 42

37.80 (28.58, 47.02)

56.29 (47.12, 65.46)

39.80 (30.24, 49.36)

56.74 (47.54, 65.94)

ACPR % difference, 95% CI

-18.49 (-31.33, -5.65)

-16.94 (-30.04, -3.83)

  1. ACPR = adequate clinical and parasitologic response, AL = artemether-lumefantrine, AZCQ = azithromycin-chloroquine fixed-dose combination, CI = confidence interval, MITT = modified intention-to-treat, PP = per-protocol.
  2. *Estimated from Kaplan-Meier curve.
  3. CI by large sample approximation to the binomial with continuity correction using the standard error estimated by the Greenwood formula.
  4. Difference calculated from rates estimated from the Kaplan-Meier curves.
  5. Note: Group-specific confidence intervals and the confidence interval for the difference between treatment groups was not calculated when all failures occurred in single group.