Table 2. Clinical Failure Rates at or before the Day 10–12 Visit, According to Study Group and Demographic and Clinical Characteristics at Entry*.
| Characteristic at Entry | Amoxicillin–Clavulanate Group (N = 144) | Placebo Group (N = 147) | All Children (N = 291) | P Value† |
|---|---|---|---|---|
| no. of children with clinical failure/total no. (%)‡ | ||||
| Exposure to other children§ | 0.007 | |||
| No | 10/73 (14) | 29/73 (40) | 39/146 (27) | |
| Yes | 13/69 (19) | 44/70 (63) | 57/139 (41) | |
| AOM-SOS score | 0.004 | |||
| ≤8 | 9/82 (11) | 35/81 (43) | 44/163 (27) | |
| >8 | 14/60 (23) | 38/62 (61) | 52/122 (43) | |
| Laterality of acute otitis media | 0.002 | |||
| Unilateral | 6/68 (9) | 29/70 (41) | 35/138 (25) | |
| Bilateral | 17/74 (23) | 44/73 (60) | 61/147 (41) | |
| Degree of tympanic membrane bulging in worse ear | <0.001 | |||
| Slight or moderate | 12/103 (12) | 46/106 (43) | 58/209 (28) | |
| Marked | 11/39 (28) | 27/37 (73) | 38/76 (50) | |
| No. of unfavorable characteristics | <0.001 | |||
| 0 | 1/19 (5) | 4/15 (27) | 5/34 (15) | |
| 1 | 4/42 (10) | 14/46 (30) | 18/88 (20) | |
| 2 | 6/44 (14) | 27/46 (59) | 33/90 (37) | |
| 3 | 8/26 (31) | 20/28 (71) | 28/54 (52) | |
| 4 | 4/11 (36) | 8/8 (100) | 12/19 (63) | |
For each characteristic, the favorable category is listed first and the unfavorable second. All the tests for interactions between study group and the individual characteristics were nonsignificant. The odds ratios for the individual unfavorable characteristics, adjusted for study group and for the remaining three characteristics, ranged from 2.0 to 2.3 (see Table 2 in the Supplementary Appendix for additional details). AOM-SOS denotes the Acute Otitis Media Severity of Symptoms scale.
For the individual characteristics, P values are for the comparison, in the study groups combined, between children with the favorable characteristic and children with the unfavorable characteristic. For the number of unfavorable characteristics, the P value is for the test for linear trend from none to four.
Data were not available for some children because of missed visits.
Exposure to other children was defined as exposure to at least three children for at least 10 hours per week.