Table 3.
Measure of Symptomatic Response | 10-Day Group (N = 242) | 5-Day Group (N = 238) | All Children (N = 480) | P Value |
---|---|---|---|---|
AOM-SOS score over period from day 6 to 14† | ||||
| ||||
All children | ||||
No. of children | 232 | 228 | 460 | |
Mean score | 1.34 ±1.76 | 1.61±1.96 | 1.47±1.86 | 0.07‡ |
| ||||
Children with clinical success§ | ||||
No. of children | 193 | 145 | 338 | |
Mean score | 1.32 ±1.81 | 1.34±1.69 | 1.33±1.76 | 0.02¶ |
| ||||
Children with clinical failure | ||||
No. of children | 33 | 73 | 106 | |
Mean score | 1.63±1.53 | 1.99±2.20 | 1.88±2.02 | |
| ||||
AOM-SOS score at the day-12-to-14 assessment | ||||
| ||||
All children | ||||
No. of children | 233 | 227 | 460 | |
Mean score | 1.20±2.06 | 1.89±2.73 | 1.54±2.44 | 0.001‡ |
| ||||
Children with clinical success§ | ||||
No. of children | 199 | 151 | 350 | |
Mean score | 1.04±2.02 | 1.27±2.02 | 1.14±2.02 | <0.001¶ |
| ||||
Children with clinical failure | ||||
No. of children | 34 | 76 | 110 | |
Mean score | 2.15±2.06 | 3.13±3.45 | 2.83±3.11 | |
| ||||
Decrease of >50% in AOM-SOS score from base-line to the day-12-to-14 assessment — no./total no. (%)|| | ||||
| ||||
All children | 211/233 (91) | 181/227 (80) | 392/460 (85) | 0.003‡ |
Children with clinical success§ | 182/199 (91) | 133/151 (88) | 315/350 (90) | <0.001¶ |
Children with clinical failure | 29/34 (85) | 48/76 (63) | 77/110 (70) |
Data were missing for some children for some analyses. Analyses included adjustments for study site, age group, exposure or nonexposure to three or more other children for 10 or more hours per week, AOM-SOS score at entry, day of diary notation, and treatment, singly or in combination as appropriate.
Day 6 marked the beginning of placebo use in place of amoxicillin–clavulanate in the 5-day group. Over the period from day 1 to day 5, during which treatment in the 10-day group and the 5-day group was uniform, the mean AOM-SOS scores in the 10-day group and the 5-day group, with adjustment for scores at entry, did not differ significantly. In children with clinical failure, the period that was considered for this analysis was from day 6 to the day preceding the day on which clinical failure was determined.
The P value is for the comparison between the 10-day group and the 5-day group.
There was no significant interaction between treatment and AOM-SOS scores in relation to clinical outcome (clinical success vs. clinical failure).
The P value is for the comparison, in the study groups combined, between children who had clinical success and those who had clinical failure.
The cutoff of 50% or less versus more than 50% was based on data from a study of minimal clinically important difference in AOM-SOS scores.12