Pharmacokinetic profile of amodiaquine and its active metabolite desethylamodiaquine in Ghanaian patients with uncomplicated falciparum malaria

Table 2 Day 28 Therapeutic efficacy of artesunate-amodiaquine fixed dose combination treatment of uncomplicated falciparum malaria in Ghanaian patients, by Intention-to-treat (ITT) and Per Protocol (PP) analysis

Treatment outcome	Analysis	Age category (years)
Treatment outcome	Analysis	Total	< 1	1–4	≥ 5
N	ITT	308	13	176	119
N	PP	294	11	168	115
Early treatment failure (ETF), n (%)	ITT	0	0	0	0
Early treatment failure (ETF), n (%)	PP	0	0	0	0
Late clinical failure (LCF), n (%)	ITT	5 (1.6)	0	3 (1.7)	2 (1.7)
Late clinical failure (LCF), n (%)	PP	5 (1.7)	0	3 (1.8)	2 (1.7)
Late parasitological failure (LPF), n (%)	ITT	12 (3.9)	0	6 (3.5)	6 (5.0)
Late parasitological failure (LPF), n (%)	PP	9 (3.1)	0	6 (3.6)	3 (2.6)
D28 PCR-uncorrected ACPR, (%)	ITT	94.5	100	94.9	93.3
D28 PCR-uncorrected ACPR, (%)	PP	95.2	100	94.6	95.7
Parasite recurrence, n	ITT	17	0	9	8
Parasite recurrence, n	PP	14	0	9	5
P. falciparum recrudescence on PCR, n	ITT	6	0	4	2
P. falciparum recrudescence on PCR, n	PP	6	0	4	2
P. falciparum reinfection on PCR, n	ITT	8	0	5	3
P. falciparum reinfection on PCR, n	PP	8	0	5	3
^aIndeterminate or missing PCR, n	ITT	3	0	0	3
^aIndeterminate or missing PCR, n	PP	0	0	0	0
Day 28 PCR-corrected ACPR, (%)	ITT	98.0	100	97.7	98.3
Day 28 PCR-corrected ACPR, (%)	PP	98.0	100	97.6	98.3

PCR: Polymerase chain reaction; ACPR: Adequate clinical and parasitological response
^aPatients with indeterminate or missing PCR results were excluded from PP and ITT analyses

ISSN: 1475-2875