Safety and efficacy of the choline analogue SAR97276 for malaria treatment: results of two phase 2, open-label, multicenter trials in African patients

Table 3 Outcomes of criteria determining treatment success

Group	1A	N = 34	1B	N = 30	1C	N = 30	1D	N = 19
Criteria	Success	Failure	Success	Failure	Success	Failure	Success	Failure	Not evaluable
Fever clearance	30 (88%)	4 (12%)	29 (97%)	1 (3%)	29 (97%)	1 (3%)	16 (84%)	1 (5%)	2 (11%)
General condition improvement	32 (94%)	2 (6%)	28 (93%)	2 (7%)	29 (97%)	1 (3%)	17 (90%)	1 (5%)	1 (5%)
Parasite reduction	23 (68%)	11 (32%)	28 (93%)	2 (7%)	23 (77%)	7 (23%)	14 (74%)	5 (26%)	0
Rescue therapy	29 (85%)	5 (15%)	29 (97%)	1 (3%)	29 (97%)	1 (3%)	15 (79%)	4 (21%)	0
Response rate for all 4 criteria	20/34 (59%)		27/30 (90%)		23/30 (77%)		13/19 (69%)
90% CI^a	(0.43–0.73)		(0.76–0.97)		(0.61–0.89)		(0.47–0.85)
95% CI^a	(0.41–0.75)		(0.73–0.98)		(0.58–0.90)		(0.43–0.87)

In the upper part of the table the four different criteria determining treatment success at 72 h are shown for the different groups. In the lower part the overall response rate together with the 90 and 95% confidence interval is shown. A positive response can only be achieved if all 4 criteria had a positive response at 72 h. (Study 1)
Group 1A: 1 day IM to adults; Group 1B: 3 days IM to adults; Group 1C: 1 day IV to adults; Group 1D: 3 days IM to children
^aConfidence interval for the response rate for all 4 criteria

ISSN: 1475-2875