| Outcome . | All Patients (N = 205) . |
|---|---|
| Primary outcome | |
| Treatment failurea,b | 11 (5.4) |
| Secondary outcomes | |
| Symptom severity—day 5 | |
| AOM-SOS Score (mean, SD) | 4.3 (4.9) |
| Change from baseline (mean, SD) | −9.9 (6.5) |
| Score ≤ 2 (n (%)) | 97 (47.3) |
| Score ≤ 2 or decrease of > 20% from baseline (n (%)) | 180 (87.8) |
| Score ≤ 2 or decrease of > 50% from baseline (n (%)) | 152 (74.1) |
| Symptom severity—day 14 | |
| AOM-SOS Score (mean, SD) | 2.4 (4.2) |
| Change from baseline (mean, SD) | −11.9 (6.2) |
| Score ≤ 2 (n (%)) | 193 (94.1) |
| Score ≤ 2 or decrease of > 20% from baseline (n (%)) | 180 (87.8) |
| Score ≤ 2 or decrease of > 50% from baseline (n (%)) | 154 (75.1) |
| Days to symptom improvement (parent reported) (median, IQR)c | 3 (1) |
| Days to symptom resolution (parent reported) (median, IQR) | 7 (3) |
| Adverse drug eventsd | |
| Parent-reported adverse drug events (n (%)) | 56 (27.3) |
| Total number of adverse drug events (n) | 74 |
| Diarrhea (n (%)) | 33 (16.1) |
| Diaper dermatitis (n (%)) | 16 (7.8) |
| Upset stomach or vomiting (n (%)) | 13 (6.3) |
| Body rash (n (%)) | 12 (5.9) |
| Severe allergic reaction requiring medical intervention (n (%)) | 0 (0.0) |
| Need for a follow-up visit due to adverse event (n (%))e | 18 (8.8) |
| Recurrence (n (%))f | 14 (6.8) |
| Treatment failure (0-14 days) or Recurrence (15-30 days) (n (n%)) | 24 (11.7%) |
| Outcome . | All Patients (N = 205) . |
|---|---|
| Primary outcome | |
| Treatment failurea,b | 11 (5.4) |
| Secondary outcomes | |
| Symptom severity—day 5 | |
| AOM-SOS Score (mean, SD) | 4.3 (4.9) |
| Change from baseline (mean, SD) | −9.9 (6.5) |
| Score ≤ 2 (n (%)) | 97 (47.3) |
| Score ≤ 2 or decrease of > 20% from baseline (n (%)) | 180 (87.8) |
| Score ≤ 2 or decrease of > 50% from baseline (n (%)) | 152 (74.1) |
| Symptom severity—day 14 | |
| AOM-SOS Score (mean, SD) | 2.4 (4.2) |
| Change from baseline (mean, SD) | −11.9 (6.2) |
| Score ≤ 2 (n (%)) | 193 (94.1) |
| Score ≤ 2 or decrease of > 20% from baseline (n (%)) | 180 (87.8) |
| Score ≤ 2 or decrease of > 50% from baseline (n (%)) | 154 (75.1) |
| Days to symptom improvement (parent reported) (median, IQR)c | 3 (1) |
| Days to symptom resolution (parent reported) (median, IQR) | 7 (3) |
| Adverse drug eventsd | |
| Parent-reported adverse drug events (n (%)) | 56 (27.3) |
| Total number of adverse drug events (n) | 74 |
| Diarrhea (n (%)) | 33 (16.1) |
| Diaper dermatitis (n (%)) | 16 (7.8) |
| Upset stomach or vomiting (n (%)) | 13 (6.3) |
| Body rash (n (%)) | 12 (5.9) |
| Severe allergic reaction requiring medical intervention (n (%)) | 0 (0.0) |
| Need for a follow-up visit due to adverse event (n (%))e | 18 (8.8) |
| Recurrence (n (%))f | 14 (6.8) |
| Treatment failure (0-14 days) or Recurrence (15-30 days) (n (n%)) | 24 (11.7%) |
aTreatment failure is defined by requiring new abx for AOM by day 14—NOT for adverse drug events; either diffabx OR abxchange =1 at 0-14 days.
bMissing data for 17 patients were imputed by multiple imputation.
cCalculated from baseline visit date to date improvement in symptoms was observed by parents.
dDay 14 ADEs were not available.
eOut of all patients, parent-reported.
fCalculated from new antibiotic required for a new ear infection, per patient survey (newabx) or chart review (abxear30).
| Outcome . | All Patients (N = 205) . |
|---|---|
| Primary outcome | |
| Treatment failurea,b | 11 (5.4) |
| Secondary outcomes | |
| Symptom severity—day 5 | |
| AOM-SOS Score (mean, SD) | 4.3 (4.9) |
| Change from baseline (mean, SD) | −9.9 (6.5) |
| Score ≤ 2 (n (%)) | 97 (47.3) |
| Score ≤ 2 or decrease of > 20% from baseline (n (%)) | 180 (87.8) |
| Score ≤ 2 or decrease of > 50% from baseline (n (%)) | 152 (74.1) |
| Symptom severity—day 14 | |
| AOM-SOS Score (mean, SD) | 2.4 (4.2) |
| Change from baseline (mean, SD) | −11.9 (6.2) |
| Score ≤ 2 (n (%)) | 193 (94.1) |
| Score ≤ 2 or decrease of > 20% from baseline (n (%)) | 180 (87.8) |
| Score ≤ 2 or decrease of > 50% from baseline (n (%)) | 154 (75.1) |
| Days to symptom improvement (parent reported) (median, IQR)c | 3 (1) |
| Days to symptom resolution (parent reported) (median, IQR) | 7 (3) |
| Adverse drug eventsd | |
| Parent-reported adverse drug events (n (%)) | 56 (27.3) |
| Total number of adverse drug events (n) | 74 |
| Diarrhea (n (%)) | 33 (16.1) |
| Diaper dermatitis (n (%)) | 16 (7.8) |
| Upset stomach or vomiting (n (%)) | 13 (6.3) |
| Body rash (n (%)) | 12 (5.9) |
| Severe allergic reaction requiring medical intervention (n (%)) | 0 (0.0) |
| Need for a follow-up visit due to adverse event (n (%))e | 18 (8.8) |
| Recurrence (n (%))f | 14 (6.8) |
| Treatment failure (0-14 days) or Recurrence (15-30 days) (n (n%)) | 24 (11.7%) |
| Outcome . | All Patients (N = 205) . |
|---|---|
| Primary outcome | |
| Treatment failurea,b | 11 (5.4) |
| Secondary outcomes | |
| Symptom severity—day 5 | |
| AOM-SOS Score (mean, SD) | 4.3 (4.9) |
| Change from baseline (mean, SD) | −9.9 (6.5) |
| Score ≤ 2 (n (%)) | 97 (47.3) |
| Score ≤ 2 or decrease of > 20% from baseline (n (%)) | 180 (87.8) |
| Score ≤ 2 or decrease of > 50% from baseline (n (%)) | 152 (74.1) |
| Symptom severity—day 14 | |
| AOM-SOS Score (mean, SD) | 2.4 (4.2) |
| Change from baseline (mean, SD) | −11.9 (6.2) |
| Score ≤ 2 (n (%)) | 193 (94.1) |
| Score ≤ 2 or decrease of > 20% from baseline (n (%)) | 180 (87.8) |
| Score ≤ 2 or decrease of > 50% from baseline (n (%)) | 154 (75.1) |
| Days to symptom improvement (parent reported) (median, IQR)c | 3 (1) |
| Days to symptom resolution (parent reported) (median, IQR) | 7 (3) |
| Adverse drug eventsd | |
| Parent-reported adverse drug events (n (%)) | 56 (27.3) |
| Total number of adverse drug events (n) | 74 |
| Diarrhea (n (%)) | 33 (16.1) |
| Diaper dermatitis (n (%)) | 16 (7.8) |
| Upset stomach or vomiting (n (%)) | 13 (6.3) |
| Body rash (n (%)) | 12 (5.9) |
| Severe allergic reaction requiring medical intervention (n (%)) | 0 (0.0) |
| Need for a follow-up visit due to adverse event (n (%))e | 18 (8.8) |
| Recurrence (n (%))f | 14 (6.8) |
| Treatment failure (0-14 days) or Recurrence (15-30 days) (n (n%)) | 24 (11.7%) |
aTreatment failure is defined by requiring new abx for AOM by day 14—NOT for adverse drug events; either diffabx OR abxchange =1 at 0-14 days.
bMissing data for 17 patients were imputed by multiple imputation.
cCalculated from baseline visit date to date improvement in symptoms was observed by parents.
dDay 14 ADEs were not available.
eOut of all patients, parent-reported.
fCalculated from new antibiotic required for a new ear infection, per patient survey (newabx) or chart review (abxear30).
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