An open randomized clinical trial in comparing two artesunate-based combination treatments on Plasmodium falciparum malaria in Nigerian children: artesunate/sulphamethoxypyrazine/pyrimethamine (fixed dose over 24 hours) versus artesunate/amodiaquine (fixed dose over 48 hours)

Table 2 Therapeutic response (PP)

Characteristics	AS + SMP (n = 229)	AS + AQ (n = 238)	p-value
Fever clearance time (Days)
Median (Range)	1.00 (1 - 2)	1.00 (1 - 2)	0.271
Parasite clearance time (Days)
Median (Range)	1.00 (1 - 7)	1.00 (1 - 3)	0.941
Proportion with Fever
Day 1	32 (12.9%)	16 (6.5%)	0.016
Day 2	5 (2.0%)	5 (2.0%)	-
Day 3	3 (1.2%)	3 (1.2%)	-
Proportion with Parasite
Day 1	66 (28.8%)	70 (29.4%)	0.888
Day 2	12 (5.3%)	9 (3.8%)	0.441
Day 3	3 (1.3%)	0 (0.0%)	0.117⁺
Proportion with Gametocyte
Day 0	16 (7.0%)	16 (6.7%)	0.910
Day 1	18 (7.9%)	15 (6.3%)	0.511
Day 2	17 (7.4%)	18 (7.6%)	0.954
Day 3	17 (7.4%)	13 (5.5%)	0.387
Day 7	13 (5.7%)	11 (4.7%)	0.636
Day 14	8 (3.5%)	5 (2.2%)	0.390
Day 21	2 (0.9%)	3 (1.3%)	0.660
Day 28	5 (2.2%)	8 (3.5%)	0.408
Treatment outcome
ACPR*	219 (95.6%)	233 (97.9%)	0.151
Recrudescence	9 (3.9%)	4 (1.7%)	0.135
Re-infection++	13 (5.7%)	4 (1.7%)	0.021
ETF*	1 (0.4%)	1 (0.4%)	-

Fisher's ⁺
*ACPR = adequate parasitological and clinical response; ETF = early treatment failure
++ Kaplan Meier

ISSN: 1475-2875