Table 2.

Efficacy Outcomes, Per Protocol and Intention-to-Treat Populations of the Fosmidomycin–Piperaquine Trial in Adults and Children in Gabon

Efficacy Outcomes	Patients Aged >14 Years	Patients Aged 5–14 Years	Patients Aged 1–5 Years	Total
Day 7 cure rate, % (95% CI), n	100% (66–100), 9	100% (91–100), 38	100% (92–100), 45a	100% (96–100), 92
Day 28 PCR-uncorrected, per-protocol population
ACPR, n	9	34	42	83
Treatment failures, n	0	0	2	2
Cumulative incidence of success, % (95% CI)	100.0% (84.5–99.4)	100.0% (84.5–99.4)	95.4% (84.5–99.4)	97.6% (90.9–99.4)
Day 28 PCR-corrected, per-protocol population
ACPR, n	9	34	42	83
Treatment failures, n	0	0	0	0
Cumulative incidence of success, % (95% CI)	100.0% (84.5–99.4)	100.0% (84.5–99.4)	100.0% (91.5–100.0)	100.0% (95.6–100.0)
Day 63 PCR-uncorrected, per-protocol population
ACPR, n	7	28	30	65
Treatment failures, n	0	2	10	12
Cumulative incidence of success, % (95% CI)	100.0% (59.0–100.0)	93.3% (77.9–99.2)	75.0% (58.8–87.3)	97.6% (90.9–99.4)
Day 63 PCR-corrected, per-protocol population
ACPR, n	7	28	30	65
Treatment failures, n	0	0	0	0
Cumulative incidence of success, % (95% CI)	100.0% (59.0–100.0)	100.0% (87.6–100.0)	100.0% (88.4–100.0)	100.0% (94.5–100.0)
0- to 48-hour parasite reduction ratio, log10	5.8	4.9	3.8	4.0
Parasite clearance time, hours
Median (range)	18 (6–36)	24 (6–60)	36 (24–60)	36 (6–60)
Fever clearance time, hours
Median (range)	18b	12 (6–36)	6 (6–48)	12 (6–48)
Proportions with gametocytes on day 7,
n/N (%; 95% CI)	0/9 (0; 0.0–33.6)	1/38 (3; 0.0–13.8)	2/48 (4; 0.5–14.2)	3/95 (3; 1.0–9.0)

Abbreviations: ACPR, adequate clinical and parasitological response; CI, confidence interval; PCR, polymerase chain reaction.

^aIncluding 10 children aged <3 years.

^bOnly 1 patient with fever in this age group.