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) |
| 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.
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) |
| 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.
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