Table 3.
Outcomes by treatment group
| 3-day amoxicillin (n=1497) | 5-day amoxicillin (n=1503) | Difference (95% CI) | |
|---|---|---|---|
| Primary | |||
| Treatment failure on or prior to Day 61 | 85 / 1442 (5.9%) | 75 / 1456 (5.2%) | 0.75% (-0.92%, 2.41%) |
| Secondary - a priori | |||
| Relapse on or prior to Day 14 if cured by Day 62 | 91 / 1326 (6.9%) | 79 / 1354 (5.8%) | 1.0% (-0.8% to 2.9%) |
| Treatment failure or relapse on or prior to Day 14 | 176 / 1411 (12.5%) | 154 / 1429 (10.8%) | 1.7% (-0.7% to 4.1%) |
| Multiple imputation for any missing primary outcome data due to withdrawal or loss to follow-up3 | Imputed for n=55 | Imputed for n=47 | 0.8% (-0.9% to 2.4%) |
| Treatment failure subgroups - a priori | |||
| Age (months) groups | 1442 | 1456 | |
| 2-11 | 57 / 832 (6.9%) | 46 / 842 (5.5%) | 1.4% (-0.9% to 3.7%) |
| 12-35 | 23 / 490 (4.7%) | 24 / 498 (4.8%) | -0.1% (-2.8% to 2.5%) |
| 36-59 | 5 / 120 (4.2%) | 5 / 116 (4.3%) | -0.1% (-5.3% to 5.0%) |
| Mid-upper arm circumference (cm)4 | 1442 | 1456 | |
| <11.5 | 0 / 0 | 0 / 0 | |
| 11.5-13.5 | 25 / 309 (8.1%) | 17 / 297 (5.7%) | 2.4% (-1.7% to 6.4%) |
| >13.5 | 60 / 1133 (5.3%) | 58 / 1159 (5.0%) | 0.3% (-1.5% to 2.1%) |
| Malaria | 1442 | 1456 | |
| Positive | 4 / 127 (3.1%) | 5 / 136 (3.7%) | -0.5% (-4.9% to 3.9%) |
| Negative | 81 / 1315 (6.2%) | 70 / 1320 (5.3%) | 0.9% (-0.9% to 2.6%) |
| Very fast breathing for age | 1442 | 1456 | |
| Positive | 5 / 68 (7.4%) | 5 / 59 (8.5%) | -1.1 (-10.6 to 8.3) |
| Negative | 80 / 1374 (5.8%) | 70 / 1397 (5%) | 0.8 (-0.9 to 2.5) |
Data are n (%). 95% CI=95% confidence interval. Some results may appear inconsistent due to rounding.
1
Difference and 95% CI adjusted for age, sex and phase.
2
Of those without treatment failure on or prior to Day 6.
3
Covariates used in imputation: treatment group, age group, sex, mother's education level, number of children in the home and number of doses taken.
4
Data not available for all randomized children.