Table 1. Selected Demographic and Clinical Characteristics, According to Study Group*.
| Characteristic | Amoxicillin–Clavulanate Group (N = 144) | Placebo Group (N = 147) | All Children (N = 291) |
|---|---|---|---|
| Age at entry — no. (%) | |||
| 6–11 mo | 83 (58) | 78 (53) | 161 (55) |
| 12–17 mo | 35 (24) | 42 (29) | 77 (26) |
| 18–23 mo | 26 (18) | 27 (18) | 53 (18) |
| Sex — no. (%) | |||
| Male | 75 (52) | 80 (54) | 155 (53) |
| Female | 69 (48) | 67 (46) | 136 (47) |
| Race — no. (%)† | |||
| White | 66 (46) | 65 (44) | 131 (45) |
| Black | 62 (43) | 58 (39) | 120 (41) |
| Other | 16 (11) | 24 (16) | 40 (14) |
| Maternal level of education — no./total no. (%) | |||
| Less than high school | 24/144 (17) | 16/146 (11) | 40/290 (14) |
| High-school graduate | 90/144 (62) | 95/146 (65) | 185/290 (64) |
| College graduate | 30/144 (21) | 35/146 (24) | 65/290 (22) |
| Type of health insurance — no./total no. (%) | |||
| Private | 43/141 (30) | 42/145 (29) | 85/286 (30) |
| Medicaid | 98/141 (70) | 103/145 (71) | 201/286 (70) |
| Exposure to other children — no. (%)‡ | |||
| Yes | 69 (48) | 72 (49) | 141 (48) |
| No | 75 (52) | 75 (51) | 150 (52) |
| AOM-SOS score§ | |||
| Baseline score — no. (%) | |||
| 3–5 | 37 (26) | 33 (22) | 70 (24) |
| 6–8 | 46 (32) | 51 (35) | 97 (33) |
| 9–11 | 46 (32) | 44 (30) | 90 (31) |
| 12–14 | 15 (10) | 19 (13) | 34 (12) |
| Mean baseline score | 7.69±2.85 | 7.90±2.87 | 7.80±2.86 |
| Laterality of acute otitis media — no. (%) | |||
| Bilateral | 75 (52) | 77 (52) | 152 (52) |
| Unilateral | 69 (48) | 70 (48) | 139 (48) |
| Degree of tympanic membrane bulging in worse ear — no. (%) | |||
| Slight | 42 (29) | 39 (27) | 81 (28) |
| Moderate | 63 (44) | 70 (48) | 133 (46) |
| Marked | 39 (27) | 38 (26) | 77 (26) |
*
There were no significant differences in characteristics between the two study groups.
†
Race was reported by the parents.
‡
Exposure to other children was defined as exposure to at least three children for at least 10 hours per week.
§
The Acute Otitis Media Severity of Symptoms (AOM-SOS) scale measures seven discrete items: tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. Parents are asked to rate these symptoms, in comparison with the child's usual state, as “none,” “a little,” or “a lot,” with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 14, with higher scores indicating greater severity of symptoms.