Trial Outcomes & Findings for Acute Otitis Media (AOM) Therapy Trial in Young Children (NCT NCT00377260)
NCT ID: NCT00377260
Last Updated: 2016-12-05
Results Overview
Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches 0 or 1. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \& fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible score was 14 and the minimum was 0. A score \>=3 was required to be enrolled in the study.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
291 participants
Primary outcome timeframe
The first 7 days on therapy
Results posted on
2016-12-05
Participant Flow
Children were recruited over 3 respiratory seasons, beginning on 11/31/2006 with the last enrollment on 3/31/2009. There were 2 enrollment sites, as well as referrals from private pediatricians. One site was a large private practice; the other was a large hospital based practice. This was for generalizability.
There were 2 children who signed consents but were not randomized. One parent withdrew consent and one child, referred from an outside practice, was found to not be eligible.
Participant milestones
| Measure |
Amoxicillin-Clavulanate
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
147
|
|
Overall Study
COMPLETED
|
142
|
142
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Amoxicillin-Clavulanate
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
Baseline Characteristics
Acute Otitis Media (AOM) Therapy Trial in Young Children
Baseline characteristics by cohort
| Measure |
Amoxicillin-Clavulanate
n=144 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=147 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
History of recurrent acute otitis media
Yes
|
21 participants
n=5 Participants
|
29 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
History of recurrent acute otitis media
No
|
123 participants
n=5 Participants
|
118 participants
n=7 Participants
|
241 participants
n=5 Participants
|
|
Age, Customized
6-11 months
|
83 participants
n=5 Participants
|
78 participants
n=7 Participants
|
161 participants
n=5 Participants
|
|
Age, Customized
12-17 months
|
35 participants
n=5 Participants
|
42 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Age, Customized
18-23 months
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Gender
Female
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Gender
Male
|
75 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Colonization With AOM Pathogens
Presence of at least one AOM pathogen
|
123 participants
n=5 Participants
|
119 participants
n=7 Participants
|
242 participants
n=5 Participants
|
|
Colonization With AOM Pathogens
Absence of any AOM pathogen
|
16 participants
n=5 Participants
|
24 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Colonization With AOM Pathogens
No culture result
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Degree of tympanic membrane bulging
Slight
|
42 participants
n=5 Participants
|
39 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Degree of tympanic membrane bulging
Moderate
|
63 participants
n=5 Participants
|
70 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Degree of tympanic membrane bulging
Marked
|
39 participants
n=5 Participants
|
38 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Ethnicity
Hispanic
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Ethnicity
Non-Hispanic
|
123 participants
n=5 Participants
|
128 participants
n=7 Participants
|
251 participants
n=5 Participants
|
|
Exposed to other children
Exposed
|
69 participants
n=5 Participants
|
72 participants
n=7 Participants
|
141 participants
n=5 Participants
|
|
Exposed to other children
Not exposed
|
75 participants
n=5 Participants
|
75 participants
n=7 Participants
|
150 participants
n=5 Participants
|
|
Health insurance status
Private
|
43 participants
n=5 Participants
|
42 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Health insurance status
Medicaid
|
98 participants
n=5 Participants
|
103 participants
n=7 Participants
|
201 participants
n=5 Participants
|
|
Health insurance status
None
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Laterality of Acute Otitis Media
Bilateral
|
75 participants
n=5 Participants
|
77 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Laterality of Acute Otitis Media
Unilateral
|
69 participants
n=5 Participants
|
70 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Maternal Education
Less than high school
|
24 participants
n=5 Participants
|
16 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Maternal Education
High school graduate
|
90 participants
n=5 Participants
|
95 participants
n=7 Participants
|
185 participants
n=5 Participants
|
|
Maternal Education
College graduate
|
30 participants
n=5 Participants
|
35 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Maternal Education
Unknown
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race
Caucasian
|
66 participants
n=5 Participants
|
65 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Race
African-American
|
62 participants
n=5 Participants
|
58 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Race
Other
|
16 participants
n=5 Participants
|
24 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Severity of symptoms score
Score of 3-5
|
37 participants
n=5 Participants
|
33 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Severity of symptoms score
Score of 6-8
|
46 participants
n=5 Participants
|
51 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Severity of symptoms score
Score of 9-11
|
46 participants
n=5 Participants
|
44 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Severity of symptoms score
Score of 12-14
|
15 participants
n=5 Participants
|
19 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Study Site
Children's Hospital of Pittsburgh (Pittsburgh, PA)
|
113 participants
n=5 Participants
|
117 participants
n=7 Participants
|
230 participants
n=5 Participants
|
|
Study Site
Armstrong Pediatrics (Kittanning, PA)
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Mean Estimated Probability of Middle Ear Effusion
Right ear
|
.42 probability of effusion
STANDARD_DEVIATION .31 • n=5 Participants
|
.39 probability of effusion
STANDARD_DEVIATION .27 • n=7 Participants
|
.41 probability of effusion
STANDARD_DEVIATION .29 • n=5 Participants
|
|
Mean Estimated Probability of Middle Ear Effusion
Left ear
|
.35 probability of effusion
STANDARD_DEVIATION .30 • n=5 Participants
|
.44 probability of effusion
STANDARD_DEVIATION .29 • n=7 Participants
|
.40 probability of effusion
STANDARD_DEVIATION .30 • n=5 Participants
|
|
Mean score of AOM-SOS
|
7.69 AOM-SOS score
STANDARD_DEVIATION 2.85 • n=5 Participants
|
7.90 AOM-SOS score
STANDARD_DEVIATION 2.87 • n=7 Participants
|
7.80 AOM-SOS score
STANDARD_DEVIATION 2.86 • n=5 Participants
|
PRIMARY outcome
Timeframe: The first 7 days on therapyPopulation: The analysis was ITT. The number of participants is equal to the number of children randomized.
Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches 0 or 1. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \& fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible score was 14 and the minimum was 0. A score \>=3 was required to be enrolled in the study.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=144 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=147 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Resolved by Day 1 - PM
|
20 participants
|
9 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Censored by Day 1 - PM
|
1 participants
|
2 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Resolved by Day 2 - AM
|
38 participants
|
28 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Censored by Day 2 - AM
|
1 participants
|
2 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Resolved by Day 2 - PM
|
50 participants
|
41 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Censored by Day 2 - PM
|
1 participants
|
3 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Resolved by Day 3 - AM
|
70 participants
|
58 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Censored by Day 3 - AM
|
1 participants
|
3 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Resolved by Day 3 - PM
|
77 participants
|
66 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Censored by Day 3 - PM
|
1 participants
|
4 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Resolved by Day 4
|
87 participants
|
78 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Censored by Day 4
|
1 participants
|
4 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Resolved by Day 5
|
96 participants
|
92 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Censored by Day 5
|
1 participants
|
4 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Resolved by Day 6
|
110 participants
|
98 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Censored by Day 6
|
1 participants
|
4 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Resolved by Day 7
|
114 participants
|
106 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
Censored by Day 7
|
30 participants
|
41 participants
|
PRIMARY outcome
Timeframe: The first 7 days on therapyTime to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches \<= 1 on two consecutive occasions. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \& fever) as 0, 1 or 2 (none, a little, a lot) \& recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 \& 3, \& once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible was 14 and the minimum 0. A score \>=3 was required to be enrolled in the study.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=144 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=147 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Resolved by Day 1 - PM
|
0 participants
|
0 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Censored by Day 1 - PM
|
1 participants
|
2 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Resolved by Day 2 - AM
|
17 participants
|
8 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Censored by Day 2 - AM
|
1 participants
|
2 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Resolved by Day 2 - PM
|
29 participants
|
20 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Censored by Day 2 - PM
|
1 participants
|
3 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Resolved by Day 3 - AM
|
34 participants
|
29 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Censored by Day 3 - AM
|
1 participants
|
3 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Resolved by Day 3 - PM
|
50 participants
|
42 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Censored by Day 3 - PM
|
1 participants
|
4 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Resolved by Day 4
|
58 participants
|
51 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Censored by Day 4
|
1 participants
|
5 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Resolved by Day 5
|
70 participants
|
63 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Censored by Day 5
|
1 participants
|
5 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Resolved by Day 6
|
80 participants
|
69 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Censored by Day 6
|
1 participants
|
5 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Resolved by Day 7
|
96 participants
|
76 participants
|
|
The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
Censored by Day 7
|
48 participants
|
71 participants
|
PRIMARY outcome
Timeframe: During the first 7 days of therapyPopulation: The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on diaries completed at home by the child's parent.
The AOM-SOS score is derived from parent scoring each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \& fever) associated with AOM as 0, 1 or 2 (none, a little, a lot). The AOM-SOS was administered twice daily the first 3 days of follow-up, then daily for 4 additional days. Symptom burden for each child is determined by calculating the weighted average of symptom scores post-enrollment over the first 7 days of therapy. Scores are weighted by 1/k, where k is the number of post-enrollment assessments taken on that day.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=143 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=144 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment
|
2.79 AOM-SOS score
Standard Error 0.16
|
3.42 AOM-SOS score
Standard Error 0.18
|
SECONDARY outcome
Timeframe: On-therapy visit. The mean day for this visit was 5.0.Population: The analysis was ITT. The number of participants equals the number of children followed at least 72 hours after the initial dose of study medication plus the number of children meeting the criteria for clinical failure less than 72 hours after the initial dose of study medication.
Clinical failure by the on-therapy visit is defined as either failure to achieve substantial improvement in symptoms, or worsening of otoscopic signs, or both.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=143 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=145 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Distribution of Clinical Failures by the On-therapy Visit According to Treatment Assignment
Clinical failures by the on therapy visit
|
5 participants
|
34 participants
|
|
The Distribution of Clinical Failures by the On-therapy Visit According to Treatment Assignment
Subjects not classified as clinical failures
|
138 participants
|
111 participants
|
SECONDARY outcome
Timeframe: End-of-therapy visit. The mean day for this visit was 11.6.Population: The analysis was ITT. The number of participants equals the number of children evaluated post therapy plus the number of children who met the criteria for clinical failure prior to the end of therapy.
Clinical failure by the end of therapy visit is defined as failure to achieve complete or virtually complete resolution of symptoms and of otoscopic signs, but without regard to the persistence of middle ear effusion.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=142 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=143 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Distribution of Clinical Failures by the End-of-therapy Visit According to Treatment Assignment
Clinical failures by the end of therapy visit
|
23 participants
|
73 participants
|
|
The Distribution of Clinical Failures by the End-of-therapy Visit According to Treatment Assignment
Subjects not classified as clinical failures
|
119 participants
|
70 participants
|
SECONDARY outcome
Timeframe: During the first 7 days of therapyPopulation: The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on AM and PM diaries completed at home by the child's parent.
The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \& fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. The maximum possible score was 14 and the minimum was 0.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=143 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=144 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment
Day 1 PM
|
5.80 AOM-SOS score
Standard Deviation 3.61
|
6.20 AOM-SOS score
Standard Deviation 3.33
|
|
The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment
Day 2 AM
|
4.12 AOM-SOS score
Standard Deviation 3.06
|
4.85 AOM-SOS score
Standard Deviation 3.54
|
|
The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment
Day 2 PM
|
3.78 AOM-SOS score
Standard Deviation 3.05
|
4.33 AOM-SOS score
Standard Deviation 3.41
|
|
The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment
Day 3 AM
|
2.86 AOM-SOS score
Standard Deviation 2.69
|
3.37 AOM-SOS score
Standard Deviation 3.04
|
|
The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment
Day 3 PM
|
2.82 AOM-SOS score
Standard Deviation 2.67
|
3.25 AOM-SOS score
Standard Deviation 2.94
|
|
The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment
Day 4
|
2.40 AOM-SOS score
Standard Deviation 2.62
|
2.68 AOM-SOS score
Standard Deviation 2.59
|
|
The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment
Day 5
|
1.93 AOM-SOS score
Standard Deviation 2.09
|
2.41 AOM-SOS score
Standard Deviation 2.59
|
|
The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment
Day 6
|
1.40 AOM-SOS score
Standard Deviation 1.69
|
2.31 AOM-SOS score
Standard Deviation 2.29
|
|
The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment
Day 7
|
1.28 AOM-SOS score
Standard Deviation 1.64
|
1.94 AOM-SOS score
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Before receiving 72 hours of study medicationPopulation: The analysis was ITT. The number of participants equals the number of children with follow-up whose parent(s) recorded AM and/or PM symptom scores in the first 3 days of treatment.
The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \& fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1 and twice daily Days 2 and 3. Each set of ratings was summed to obtain an Acute Otitis Media-Severity of Symptoms (AOM-SOS) score. We compared a child's AOM-SOS scores in the first 72 hours to his/her score at enrollment to determine if a child's symptoms got worse (score increased) or remained unchanged or improved (score remained same or decreased).
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=143 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=143 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Distribution of Children Developing Worsening Symptoms Prior to Receiving 72 Hours of Study Medication According to Treatment Assignment
Number of children with worsening symptoms
|
31 Participants
|
39 Participants
|
|
The Distribution of Children Developing Worsening Symptoms Prior to Receiving 72 Hours of Study Medication According to Treatment Assignment
Number of children unchanged or improved
|
112 Participants
|
104 Participants
|
SECONDARY outcome
Timeframe: The first 10 days of follow-upPopulation: The analysis was ITT. The participants for analysis were the children with follow-up.
The parents were asked to complete a memory aid for the first 10 days of the study. One item asked them to record medications administered to the child in addition to the study medication. The data presented shows the mean number of times analgesic, i.e. ibuprofen or acetaminophen, was administered.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=143 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=146 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Mean Number of Times Analgesic Medication Was Administered to the Child According to Treatment Assignment
|
.37 times analgesic was administered
Standard Deviation .48
|
.43 times analgesic was administered
Standard Deviation .48
|
SECONDARY outcome
Timeframe: We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this visit was 22.8.Population: The analysis was ITT. The number of participants equals the number of children randomized.
Analysis was limited to those adverse events identified as being associated with either the study medication or the antimicrobials administered to children who were treatment failures or as being a complication of acute otitis media.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=144 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=147 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment
Mastoiditis
|
0 participants
|
1 participants
|
|
The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment
Perforation of tympanic membrane
|
1 participants
|
7 participants
|
|
The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment
Protocol-defined diarrhea
|
36 participants
|
22 participants
|
|
The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment
Diaper dermatitis
|
73 participants
|
51 participants
|
|
The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment
Oral thrush
|
7 participants
|
1 participants
|
|
The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment
Vomiting
|
12 participants
|
12 participants
|
|
The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment
Rash
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: End-of-therapy visit. The mean day for this visit was 11.6.Population: The analysis was ITT. The number of participants equals the number of children with NP culture results at the end-of-therapy visit.
AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the end of therapy visit.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=130 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=131 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment
Presence of Streptococcus pyogenes
|
0 participants
|
3 participants
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment
Absence of Streptococcus pyogenes
|
130 participants
|
128 participants
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment
Presence of Streptococcus pneumoniae
|
18 participants
|
46 participants
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment
Absence of Streptococcus pneumoniae
|
112 participants
|
85 participants
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment
Presence of at least one AOM pathogen
|
63 participants
|
88 participants
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment
Absence of any AOM pathogen
|
67 participants
|
43 participants
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment
Presence of Haemophilus influenzae
|
45 participants
|
44 participants
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment
Absence of Haemophilus influenzae
|
85 participants
|
87 participants
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment
Presence of Moraxella catarrhalis
|
9 participants
|
38 participants
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment
Absence of Moraxella catarrhalis
|
121 participants
|
93 participants
|
SECONDARY outcome
Timeframe: End-of-therapy visit. The mean day for this visit was 11.6.Population: The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the end-of-therapy visit.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=130 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=130 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the End-of-therapy Visit According to Treatment Assignment
Colonization with penicillin-susceptible S. pn
|
1 participants
|
28 participants
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the End-of-therapy Visit According to Treatment Assignment
No colonization with penicillin-susceptible S. pn
|
129 participants
|
102 participants
|
SECONDARY outcome
Timeframe: Follow-up visit. The mean day for this visit was 22.8.Population: The analysis was ITT. The number of participants equals the number of children with NP culture results at the follow-up visit.
AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the follow-up visit.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=128 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=130 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment
Presence of at least one AOM pathogen
|
76 participant
|
89 participant
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment
Absence of any AOM pathogen
|
52 participant
|
41 participant
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment
Presence of Streptococcus pneumoniae
|
26 participant
|
42 participant
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment
Absence of Streptococcus pneumoniae
|
102 participant
|
88 participant
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment
Presence of Haemophilus influenzae
|
38 participant
|
38 participant
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment
Absence of Haemophilus influenzae
|
90 participant
|
92 participant
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment
Presence of Moraxella catarrhalis
|
29 participant
|
31 participant
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment
Absence of Moraxella catarrhalis
|
99 participant
|
99 participant
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment
Presence of Streptococcus pyogenes
|
1 participant
|
0 participant
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment
Absence of Streptococcus pyogenes
|
127 participant
|
130 participant
|
SECONDARY outcome
Timeframe: Follow-up visit. The mean day for this visit was 22.8.Population: The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the follow-up visit.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=128 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=129 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the Follow-up Visit
Colonization with penicillin-susceptible S. pn
|
7 participants
|
17 participants
|
|
The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the Follow-up Visit
No colonization with penicillin-susceptible S. pn
|
121 participants
|
112 participants
|
SECONDARY outcome
Timeframe: On-therapy visit. The mean day for this visit was 5.0.Population: The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the on-therapy visit.
For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=121 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=121 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the On-therapy Visit According to Treatment Assignment
Right ear
|
.36 probability of effusion
Standard Deviation .29
|
.42 probability of effusion
Standard Deviation .29
|
|
The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the On-therapy Visit According to Treatment Assignment
Left ear
|
.39 probability of effusion
Standard Deviation .31
|
.48 probability of effusion
Standard Deviation .29
|
SECONDARY outcome
Timeframe: End-of-therapy visit. The mean day for this visit was 11.6.Population: The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the end-of-therapy visit.
For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=120 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=119 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the End-of-therapy Visit According to Treatment Assignment
Right ear
|
.32 probability of effusion
Standard Deviation .27
|
.41 probability of effusion
Standard Deviation .28
|
|
The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the End-of-therapy Visit According to Treatment Assignment
Left ear
|
.33 probability of effusion
Standard Deviation .28
|
.41 probability of effusion
Standard Deviation .27
|
SECONDARY outcome
Timeframe: Follow-up visit. The mean day for this visit was 22.8.Population: The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.
For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=129 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=121 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the Follow-up Visit According to Treatment Assignment
Right ear
|
.28 probability of effusion
Standard Deviation .28
|
.32 probability of effusion
Standard Deviation .29
|
|
The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the Follow-up Visit According to Treatment Assignment
Left ear
|
.27 probability of effusion
Standard Deviation .30
|
.37 probability of effusion
Standard Deviation .31
|
SECONDARY outcome
Timeframe: This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.Population: The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.
At each visit parents were asked if they had taken their child to his/her primary care physician since the last contact. Medical records were also reviewed.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=143 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=146 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Mean Number of Visits to a Primary Care Provider (PCP) According to Treatment Assignment
|
.15 visits to PCP
Standard Deviation .40
|
.23 visits to PCP
Standard Deviation .50
|
SECONDARY outcome
Timeframe: This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.Population: The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.
At each visit we asked parents if they had to take their child to the emergency department. We also reviewed medical records to assure even more accurate reporting.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=143 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=146 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Mean Number of Emergency Room Visits According to Treatment Assignment
|
.07 visits to ER
Standard Deviation .26
|
.07 visits to ER
Standard Deviation .25
|
SECONDARY outcome
Timeframe: This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.Population: The analysis was ITT. The participants for analysis were the children with follow-up.
This is the number of times, in the course of the study, a child required treatment with an antibiotic other than the blinded study medication.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=143 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=146 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Mean Number of Antibiotic Prescriptions, Exclusive of Study Medication, According to Treatment Assignment
|
.35 antibiotic prescriptions
Standard Deviation .58
|
.75 antibiotic prescriptions
Standard Deviation .73
|
SECONDARY outcome
Timeframe: This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.Population: The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.
At each visit, parent or parents were asked if their child's illness had caused either parent to miss a day or partial day of work. The total number of visits is summed across all participants in the respective treatment arms.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=143 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=146 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Having Missed Work According to Treatment Assignment
|
33 visits
|
33 visits
|
SECONDARY outcome
Timeframe: This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.Population: The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.
At each visit, parent or parents were asked if their child's illness had caused them to make alternative daycare arrangements. The total number of visits is summed across all participants in the respective treatment arms.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=143 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=146 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Making Special Daycare Arrangements According to Treatment Assignment
|
22 visits
|
24 visits
|
SECONDARY outcome
Timeframe: On-therapy visit. The mean day for this visit was 5.0.Population: The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the on-therapy visit.
Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=139 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=142 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the On-therapy Visit According to Treatment Assignment
|
4.19 parental satisfaction score
Standard Deviation 0.97
|
4.13 parental satisfaction score
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: End-of-therapy visit. The mean day for this visit was 11.6.Population: The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the end-of-therapy visit.
Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=138 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=140 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the End-of-therapy Visit According to Treatment Assignment
|
4.40 parental satisfaction score
Standard Deviation 0.92
|
4.12 parental satisfaction score
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Follow-up visit. The mean day for this visit was 22.8.Population: The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the follow-up visit.
Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.
Outcome measures
| Measure |
Amoxicillin-Clavulanate
n=139 Participants
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=139 Participants
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the Follow-up Visit According to Treatment Assignment
|
4.53 parental satisfaction score
Standard Deviation 0.89
|
4.17 parental satisfaction score
Standard Deviation 1.12
|
Adverse Events
Amoxicillin-Clavulanate
Serious events: 0 serious events
Other events: 117 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amoxicillin-Clavulanate
n=144 participants at risk
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=147 participants at risk
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
Ear and labyrinth disorders
Mastoiditis
|
0.00%
0/144 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
0.68%
1/147 • Number of events 1 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/144 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
0.68%
1/147 • Number of events 1 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
Other adverse events
| Measure |
Amoxicillin-Clavulanate
n=144 participants at risk
Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
|
Placebo
n=147 participants at risk
Reconstituted placebo in 2 divided doses for 10 days.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma or wheezing
|
2.8%
4/144 • Number of events 4 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
6.8%
10/147 • Number of events 10 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
Eye disorders
Conjunctivitis
|
4.2%
6/144 • Number of events 6 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
7.5%
11/147 • Number of events 12 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
Skin and subcutaneous tissue disorders
Diaper dermatitis
|
55.6%
80/144 • Number of events 91 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
38.8%
57/147 • Number of events 64 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
General disorders
Fever
|
5.6%
8/144 • Number of events 8 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
5.4%
8/147 • Number of events 8 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
Gastrointestinal disorders
Gastroenteritis
|
4.9%
7/144 • Number of events 7 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
6.1%
9/147 • Number of events 9 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
Gastrointestinal disorders
Oral thrush
|
4.9%
7/144 • Number of events 7 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
0.68%
1/147 • Number of events 1 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
Gastrointestinal disorders
Protocol defined diarrhea
|
25.0%
36/144 • Number of events 40 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
16.3%
24/147 • Number of events 25 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
General disorders
Teething
|
8.3%
12/144 • Number of events 13 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
10.2%
15/147 • Number of events 15 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
22.9%
33/144 • Number of events 35 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
23.1%
34/147 • Number of events 36 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
Skin and subcutaneous tissue disorders
Viral exanthem
|
4.2%
6/144 • Number of events 6 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
0.00%
0/147 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
General disorders
Viral illness
|
4.2%
6/144 • Number of events 6 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
4.1%
6/147 • Number of events 6 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
15/144 • Number of events 18 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
10.9%
16/147 • Number of events 16 • We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.
A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.
|
Additional Information
Efficacy of Antimicrobials in Young children with Acute Otitis Media
Children's Hospital of Pittsburgh of UPMC
Phone: 412-692-5249
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place