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Table 2 Efficacy evaluation on Day 28 after PCR correction* Intention-To-Treat Analysis

From: Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial

Efficacy evaluation

AS-SMP

3 days

(N = 476)

AS-SMP

24 hours

(N = 458)

AL

3 days

(N = 450)

Possible failure – n (%, 95%CI)

15(3.2%,1.8–5.1)

26 (5.7%,3.7–8.2)

33(7.3%,5.1–10.1)

ETF – n (%)

0

0

1(0.2%)

LCF – n (%, 95%CI)

3 (0.6%,0.1–1.8)

2 (0.4%,0.1–1.6)

0

LPF – n (%)

0

0

0

ACPR – n (%, 95%CI)

457 (96.0%,93.8–97.6)

429(93.7,91.0–95.7%)

414 (92.0,89.1–94.3%)

  1. *Possible failure: lost to follow-up or withdrawal (a subject** who received high dose of treatment or subjects antibiotics with anti-malarial activity or malaria smear results invalidated after quality control) or subjects for which filters paper were not analyzed or were undetermined result by PCR
  2. **One subject received on day 0 one dose of a junior tablet of AS-SMP instead of a baby tablet as described in the study procedures and treatment. There was no adverse event found to be related to that misuse of the study drug.