Table 3.
PCR uncorrected efficacy of AN vs DHP in all malaria, Indonesia
| Outcome | Artemisinin- naphthoquine (AN) | Dihydroartemisinin-piperaquine (DHP) | P | Overall |
|---|---|---|---|---|
|
ACPR/Treatment Success (%, 95% CL) |
|
|
|
|
|
ITT |
179 [89.1 (84.7–93.4)] |
180 [90.0 (85.8–94.2)] |
0.76 |
359 [89.5 (86.1–92.3)] |
|
Modified ITT |
179 [92.3 (88.5–96.0)] |
180 [94.7 (91.6–97.9)] |
0.33 |
359 [93.5 (90.5–95.7)] |
|
Per Protocol |
179 [93.7 (90.3–97.2)] |
180 [96.3 (93.5–99.0)] |
0.26 |
359 [95.0 (92.3–96.9)] |
|
Late Clinical Failure-LCF (%, 95% CL) |
|
|
|
|
|
ITT |
5 [2.5 (0.3–4.6)] |
1 [0.5 (0.5–1.5)] |
0.10 |
6 [1.5 (0.6–3.2)] |
|
Modified ITT |
5 [2.6 (0.3–4.8)] |
1 [0.5 (0.5–1.6)] |
0.10 |
6 [1.6 (0.6–3.4)] |
|
Per Protocol |
5 [2.6 (0.4–4.9)] |
1 [0.5 (0.5–1.6)] |
0.10 |
6 [1.6 (0.6–3.4)] |
|
Late Parasitological Failure-LPF (%, 95% CL) |
|
|
|
|
|
ITT |
7 [3.5 (0.9–6.0)] |
6 [3.0 (0.6–5.4)] |
0.78 |
13 [3.2 (1.7–5.5)] |
|
Modified ITT |
7 [3.6 (1.0–6.2)] |
6 [3.2 (0.7–5.6)] |
0.81 |
13 [3.4 (1.8–5.7)] |
|
Per Protocol |
7 [3.7 (1.0–6.3)] |
6 [3.2 (0.7–5.7)] |
0.81 |
13 [3.4 (1.8–5.8)] |
|
“Other Failures” (%, 95% CL) |
|
|
|
|
|
ITT |
10 [5.0 (2.0–8.0)] |
13 [6.5 (3.1–9.9)] |
0.51 |
23 [5.7 (3.7–8.5)] |
|
Modified ITT |
3 [1.5 (0.2–3.3)] |
3 [1.6 (0.2–3.4)] |
0.98 |
6 [1.6 (0.6–3.4)] |
| Per Protocol | 0 | 0 | 0 |
All protocol violations, withdrawn consents, and lost to follow up were classified as “other failures” in ITT analysis.
All protocol violations and withdrawn consents were classified as “other failures” in modified ITT analysis.