Effectiveness and safety of artesunate–amodiaquine versus artemether–lumefantrine for home-based treatment of uncomplicated Plasmodium falciparum malaria among children 6–120 months in Yaoundé, Cameroon: a randomized trial

Table 2 Primary outcome evaluation of in vivo effectiveness of AS-AQ and AL for the treatment of uncomplicated Plasmodium falciparum malaria day 28 (ITT and PP analyses)

Effectiveness evaluation	AS-AQ (95% CI)	AL (95% CI)	P-value
ITT analysis without PCR correction	n = 114	n = 128	0.644
ETF	3	4
LCF	1	2
LPF	0	2
ACPR	94 (82.5%, 74.2–88.9)	107 (83.6%, 76.0–89.6)
Persistent vomiting of study drug, LTFU, WT and PV	16	13
PP analysis without PCR correction	n = 98	n = 115	0.720
ETF	3	4
LCF	1	2
LPF	0	2
ACPR	94 (95.9%, 89.8–98.9)	107 (93.0%, 86.8–97.0)
ITT analysis with PCR correction	n = 114	n = 128	0.685
ETF	3	4
LCF	0	0
LPF	0	1
ACPR	94 (83.2%, 75.0–89.6)	107 (85.6%, 78.2–91.2)
Persistent vomiting of study drug, LTFU, WT and PV	16	13
Reinfection	1	3
PP analysis with PCR correction	n = 97	n = 112	0.797
ETF	3	4
LCF	0	0
LPF	0	1
ACPR	94 (96.9%, 91.2–99.4)	107 (95.5%, 89.9–98.5)
Reinfection	1	3

ITT Intention-to-treat, PP Per protocol, n Number of participants enrolled on day 0 or followed-up until day 28, AS-AQ Artesunate-amodiaquine, AL Artemether-lumefantrine, ETF Early treatment failure, LCF Late clinical failure, LPF Late parasitological failure, ACPR Adequate clinical and parasitological response, LTFU Lost to follow-up, WT Withdrawn, PV Protocol violation, CI Confidence interval at 95%, In the PP analysis with PCR correction, the re-infected cases were not used to determine ACPR

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