Table 2. Outcomes by Treatment Group.
| Outcome | Children, No./Total No. (%) | Relative Risk (95% CI) | Difference, % (95% CI) | |
|---|---|---|---|---|
| Amoxicillin (n = 564) | Placebo (n = 562) | |||
| Primary | ||||
| Treatment failure on or prior to day 4a | 22/552 (4.0) | 38/543 (7.0) | 1.78 (1.07 to 2.97) | 3.0 (0.4 to 5.7) |
| Secondary a priori | ||||
| Relapse on or prior to day 14 if cured by day 4b | 34/530 (6.4) | 26/505 (5.1) | 0.80 (0.49 to 1.32) | 1.3 (−4.1 to 1.6) |
| Treatment failure or relapse on or prior to day 14 | 56/552 (10.1) | 64/543 (11.8) | 1.16 (0.83 to 1.63) | 1.6 (−2.1 to 5.4) |
| As treated referent ≥80 amoxicillin dosesc | 14/541 (2.6) | |||
| Partial adherence to amoxicillin (0 < adherence < 80) | 3/6 (50.0) | 19.3 (7.45 to 50.1) | 47.0 (6.8 to 87.1) | |
| Adherent to placebod | 36/541 (6.7) | 2.57 (1.40 to 4.71) | 4.1 (1.6 to 6.6) | |
| Multiple imputatione | 1.76 (1.06 to 2.94) | 3.2 (0.4 to 5.9) | ||
| Subgroups a priori | ||||
| Age groups, mo | ||||
| 2-11 | 10/189 (5.3) | 15/187 (8.0) | 1.52 (0.70 to 3.29) | 2.7 (−2.3 to 7.8) |
| 12-35 | 9/252 (3.6) | 17/245 (6.9) | 1.87 (0.75 to 4.69) | 3.4 (−0.6 to 7.3) |
| 36-59 | 3/111 (2.7) | 6/111 (5.4) | 2.21 (0.79 to 6.16) | 2.7 (−2.5 to 7.9) |
| Fast breathing, RRf | ||||
| 2-11 mo | ||||
| 50-59 | 5/131 (3.8) | 12/140 (8.6) | 2.25 (0.81 to 6.20) | 4.8 (−0.9 to 10.4) |
| 60-69 | 4/52 (7.7) | 3/46 (6.5) | 0.85 | −1.2 |
| ≥70 | 1/5 (20.0) | 0/1 (0) | 0 | −20.0 |
| 12-23 mo | ||||
| 40-49 | 3/78 (3.8) | 4/73 (5.5) | 1.42 | 1.6 |
| 50-59 | 2/64 (3.1) | 6/49 (12.2) | 3.92 | 9.1 |
| ≥60 | 2/13 (15.4) | 1/8 (12.5) | 0.81 | −2.9 |
| 24-59 mo | ||||
| 40-49 | 4/153 (2.6) | 8/155 (5.2) | 1.97 (0.61 to 6.42) | 2.5 (−1.8 to 6.9) |
| 50-59 | 1/50 (2.0) | 3/66 (4.5) | 2.27 | 2.5 |
| ≥60 | 0/5 (0) | 1/5 (20.0) | ND | 20.0 |
| Mid–upper arm circumference, cmf | ||||
| <11.5 | 0 | 0 | ND | ND |
| 11.5-13.5 | 1/32 (3.1) | 6/43 (14.0) | 4.46 | 10.8 |
| >13.5 | 21/519 (4.0) | 32/500 (6.4) | 1.58 (0.92 to 2.71) | 2.4 (−0.4 to 5.1) |
| Malaria | ||||
| Positive | 0/72 (0) | 1/65 (1.5) | ND | 1.5 |
| Negative | 22/480 (4.6) | 37/478 (7.7) | 1.69 (1.01 to 2.82) | 3.2 (0.1 to 6.2) |
Abbreviations: ND, not determined; RR, respiratory rate.
a
Difference and 95% CI adjusted for stratification variables age and phase.
b
Of those without treatment failure on or prior to day 4.
c
Excluding treatment failures within 2 hours; difference and CI adjusted for age group, sex, and study phase.
d
All children in the placebo group were considered adherent to placebo in the as-treated analysis.
e
Covariates used in imputation were treatment group, age group, sex, and mother’s educational level.
f
Data not available for all randomized children.