Efficacy and safety of a combination of azithromycin and chloroquine for the treatment of uncomplicated Plasmodium falciparum malaria in two multi-country randomised clinical trials in African adults

Table 2 Summary of efficacy outcomes at Day 28 in the parasitological per protocol population

	Study 1134		Study 1155
	AZCQ 1,000 mg	MQ 1,250 mg	AZCQ 1,000 mg	MQ 1,250 mg
All treated, N	114	115	113	116
PP population, n	103	103	107	112
PCR-corrected
Eradicated, n (%) (95% CI)	101 (98.1) (94.9, 100)^a	102 (99.0) (96.7, 100)^a	107 (100.0) (96.6, 100)	111 (99.1) (96.9, 100)
Difference, % (95% CI)	-0.97 (-5.23, 3.29)^a		0.89 (-1.77, 3.56)
ETF, n (%)	0	1 (1.0)	0	1 (0.9)
LTF, n (%)	2 (1.9)	0	0	0
LPF, n (%)	2	0	0	0
LCF, n (%)	0	0	0	0
Median fever clearance time, days	<0.5	0.5	1.5	1.0
Median parasite clearance time, h	48	36	44	40

^a95.04% CI (small adjustment to the 95% CI required in order to account for a planned interim look at the primary efficacy outcome).
AZCQ 1,000 mg, azithromycin 1,000 mg plus chloroquine 600-mg base; CI, confidence interval; ETF, early treatment failure; LCF, late clinical failure; LPF, late parasitological failure; LTF, late treatment failure; MQ, mefloquine hydrochloride; PCR, polymerase chain reaction; PP, per protocol.

ISSN: 1475-2875