Trial Outcomes & Findings for Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit? (NCT NCT02554383)
NCT ID: NCT02554383
Last Updated: 2023-06-29
Results Overview
The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) \& electronically on diaries evenings Days 2-11. Pathogens cultured were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.
COMPLETED
PHASE3
515 participants
Days 2 to 11
2023-06-29
Participant Flow
Children determined to be eligible for the study and whose parents agreed to participation were randomized to one of two treatments arms. At each site of enrollment, within stratum defined by the presence/absence of colored (yellow or green) nasal discharge, children were randomized 1:1 in blocks of four to receive either twice daily amoxicillin-clavulanate or matching placebo. The analyses of study data were based on the randomized treatment assignment.
Participant milestones
| Measure |
Amoxicillin-clavulanate
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
|
Placebo
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
|
|---|---|---|
|
Overall Study
STARTED
|
257
|
258
|
|
Overall Study
COMPLETED
|
234
|
239
|
|
Overall Study
NOT COMPLETED
|
23
|
19
|
Reasons for withdrawal
| Measure |
Amoxicillin-clavulanate
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
|
Placebo
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
|
|---|---|---|
|
Overall Study
Ineligible
|
3
|
2
|
|
Overall Study
Parent completed 0 diaries by Day 4 and 0 diaries Days 5-11
|
8
|
6
|
|
Overall Study
Parent completed 0 diaries by Day 4 and >=1 diary Days 5-11
|
0
|
2
|
|
Overall Study
Parent completed >=1 diary by Day 4, but <2 diaries Days 2-4 or <3 diaries Days 5-11
|
12
|
9
|
Baseline Characteristics
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Baseline characteristics by cohort
| Measure |
Amoxicillin-clavulanate
n=254 Participants
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
|
Placebo
n=256 Participants
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
|
Total
n=510 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
2 - 5 years
|
159 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Age, Customized
6 - 12 years
|
95 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
230 Participants
n=5 Participants
|
222 Participants
n=7 Participants
|
452 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
91 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
128 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Study Site
Pittsburgh, PA
|
196 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
390 Participants
n=5 Participants
|
|
Study Site
Philadelphia, PA
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Study Site
Bardstown, KY
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Study Site
Madison, WI
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Study Site
Morgantown, WV
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Study Site
Gresham, OR
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
History of Asthma
Yes
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
History of Asthma
No
|
208 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
416 Participants
n=5 Participants
|
|
History of Allergic Rhinitis
Yes
|
78 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
History of Allergic Rhinitis
No
|
176 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
|
Fever
Yes
|
120 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Fever
No
|
134 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Exposure to Other Children
Yes
|
200 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
417 Participants
n=5 Participants
|
|
Exposure to Other Children
No
|
54 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Type of Presentation
Persistent
|
180 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
|
Type of Presentation
Worsening
|
74 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Pediatric Rhinosinusitis Symptom Scale (PRSS) Score
9 -15
|
39 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Pediatric Rhinosinusitis Symptom Scale (PRSS) Score
16 -20
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Pediatric Rhinosinusitis Symptom Scale (PRSS) Score
21 -25
|
62 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Pediatric Rhinosinusitis Symptom Scale (PRSS) Score
26 -30
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Pediatric Rhinosinusitis Symptom Scale (PRSS) Score
31 -35
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Pediatric Rhinosinusitis Symptom Scale (PRSS) Score
36 -40
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Pathogens Cultured from Nasopharynx
Yes
|
178 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
|
Pathogens Cultured from Nasopharynx
No
|
76 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Pathogens Cultured from Nasopharynx
Unknown
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Colored Nasal Discharge
Yes
|
171 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
340 Participants
n=5 Participants
|
|
Colored Nasal Discharge
No
|
83 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 2 to 11Population: The analysis was intention-to-treat (ITT). The overall number of participants analyzed is equal to the number of children randomized \& eligible who had results of a nasopharyngeal culture at enrollment and whose parent completed the PRSS at least once Days 2 to 11. For any given day, the total number analyzed plus the total number without diary data available on that day is equal to the overall number of participants analyzed for the respective Arm/Group.
The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) \& electronically on diaries evenings Days 2-11. Pathogens cultured were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.
Outcome measures
| Measure |
Amoxicillin-clavulanate
n=246 Participants
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
|
Placebo
n=247 Participants
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
|
|---|---|---|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 2
|
17.3 Score on a scale
Standard Deviation 7.8
|
18.6 Score on a scale
Standard Deviation 7.6
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 3
|
13.9 Score on a scale
Standard Deviation 7.7
|
16.6 Score on a scale
Standard Deviation 7.5
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 4
|
11.8 Score on a scale
Standard Deviation 7.9
|
13.9 Score on a scale
Standard Deviation 7.6
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 5
|
10.1 Score on a scale
Standard Deviation 7.6
|
12.0 Score on a scale
Standard Deviation 7.0
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 6
|
8.5 Score on a scale
Standard Deviation 7.1
|
10.9 Score on a scale
Standard Deviation 6.9
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 7
|
7.3 Score on a scale
Standard Deviation 6.7
|
8.9 Score on a scale
Standard Deviation 6.4
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 8
|
6.4 Score on a scale
Standard Deviation 6.7
|
8.3 Score on a scale
Standard Deviation 6.9
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 9
|
4.9 Score on a scale
Standard Deviation 5.8
|
7.4 Score on a scale
Standard Deviation 6.6
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 10
|
4.2 Score on a scale
Standard Deviation 5.4
|
6.0 Score on a scale
Standard Deviation 5.9
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 11
|
3.7 Score on a scale
Standard Deviation 5.1
|
5.8 Score on a scale
Standard Deviation 6.5
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 2
|
19.5 Score on a scale
Standard Deviation 7.3
|
18.7 Score on a scale
Standard Deviation 7.2
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 3
|
15.5 Score on a scale
Standard Deviation 8.1
|
15.5 Score on a scale
Standard Deviation 7.2
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 4
|
11.9 Score on a scale
Standard Deviation 7.4
|
12.5 Score on a scale
Standard Deviation 6.7
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 5
|
10.3 Score on a scale
Standard Deviation 7.4
|
10.5 Score on a scale
Standard Deviation 6.7
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 6
|
8.1 Score on a scale
Standard Deviation 7.1
|
9.4 Score on a scale
Standard Deviation 7.0
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 7
|
6.9 Score on a scale
Standard Deviation 6.5
|
8.3 Score on a scale
Standard Deviation 6.7
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 8
|
6.2 Score on a scale
Standard Deviation 6.4
|
7.4 Score on a scale
Standard Deviation 6.8
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 9
|
5.4 Score on a scale
Standard Deviation 6.1
|
6.3 Score on a scale
Standard Deviation 6.7
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 10
|
4.9 Score on a scale
Standard Deviation 5.9
|
5.5 Score on a scale
Standard Deviation 6.5
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 11
|
4.1 Score on a scale
Standard Deviation 5.5
|
4.1 Score on a scale
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: Days 2 to 11Population: The analysis was ITT. The overall number of participants analyzed is equal to the number of children randomized \& eligible whose parent completed the PRSS at least once Days 2 to 11. For any given day, the total number analyzed plus the total number without diary data available on that day is equal to the overall number of participants analyzed for the respective Arm/Group.
The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) \& electronically on diaries evenings Days 2-11. Nasal discharge, either yellow or green, was considered colored.
Outcome measures
| Measure |
Amoxicillin-clavulanate
n=246 Participants
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
|
Placebo
n=250 Participants
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
|
|---|---|---|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Presence of colored nasal discharge at enrollment - Day 2
|
18.6 Score on a scale
Standard Deviation 7.9
|
19.0 Score on a scale
Standard Deviation 7.2
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Presence of colored nasal discharge at enrollment - Day 3
|
14.8 Score on a scale
Standard Deviation 8.3
|
16.6 Score on a scale
Standard Deviation 7.1
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Presence of colored nasal discharge at enrollment - Day 4
|
12.1 Score on a scale
Standard Deviation 8.1
|
13.7 Score on a scale
Standard Deviation 7.1
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Presence of colored nasal discharge at enrollment - Day 5
|
10.8 Score on a scale
Standard Deviation 7.8
|
11.3 Score on a scale
Standard Deviation 6.8
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Presence of colored nasal discharge at enrollment - Day 6
|
8.6 Score on a scale
Standard Deviation 7.1
|
10.5 Score on a scale
Standard Deviation 6.8
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Presence of colored nasal discharge at enrollment - Day 7
|
7.4 Score on a scale
Standard Deviation 6.8
|
8.8 Score on a scale
Standard Deviation 6.4
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Presence of colored nasal discharge at enrollment - Day 8
|
6.4 Score on a scale
Standard Deviation 6.4
|
8.2 Score on a scale
Standard Deviation 7.1
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Presence of colored nasal discharge at enrollment - Day 9
|
5.1 Score on a scale
Standard Deviation 6.1
|
7.0 Score on a scale
Standard Deviation 6.7
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Presence of colored nasal discharge at enrollment - Day 10
|
4.4 Score on a scale
Standard Deviation 5.5
|
5.7 Score on a scale
Standard Deviation 5.9
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Presence of colored nasal discharge at enrollment - Day 11
|
3.7 Score on a scale
Standard Deviation 5.2
|
5.2 Score on a scale
Standard Deviation 5.9
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Absence of colored nasal discharge at enrollment - Day 2
|
16.4 Score on a scale
Standard Deviation 7.1
|
17.6 Score on a scale
Standard Deviation 8.3
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Absence of colored nasal discharge at enrollment - Day 3
|
13.3 Score on a scale
Standard Deviation 6.8
|
15.6 Score on a scale
Standard Deviation 7.9
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Absence of colored nasal discharge at enrollment - Day 4
|
11.1 Score on a scale
Standard Deviation 7.0
|
12.9 Score on a scale
Standard Deviation 8.0
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Absence of colored nasal discharge at enrollment - Day 5
|
9.0 Score on a scale
Standard Deviation 6.8
|
12.1 Score on a scale
Standard Deviation 7.1
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Absence of colored nasal discharge at enrollment - Day 6
|
7.8 Score on a scale
Standard Deviation 7.1
|
10.5 Score on a scale
Standard Deviation 7.3
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Absence of colored nasal discharge at enrollment - Day 7
|
6.7 Score on a scale
Standard Deviation 6.3
|
8.8 Score on a scale
Standard Deviation 6.7
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Absence of colored nasal discharge at enrollment - Day 8
|
6.1 Score on a scale
Standard Deviation 6.9
|
7.7 Score on a scale
Standard Deviation 6.5
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Absence of colored nasal discharge at enrollment - Day 9
|
4.9 Score on a scale
Standard Deviation 5.5
|
7.3 Score on a scale
Standard Deviation 6.5
|
|
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Absence of colored nasal discharge at enrollment - Day 10
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4.5 Score on a scale
Standard Deviation 5.6
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6.2 Score on a scale
Standard Deviation 6.4
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The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Absence of colored nasal discharge at enrollment - Day 11
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4.0 Score on a scale
Standard Deviation 5.2
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5.7 Score on a scale
Standard Deviation 6.9
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SECONDARY outcome
Timeframe: Day of enrollment to the day of the follow-up visit. The mean length of actual follow-up was 13.4 days. For each child with incomplete follow-up, multiple imputation was used and PRSS scores for the remaining days were imputed.Population: The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible.
The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment), electronically evenings Days 2-11 \& at the follow-up visit. If, compared to the Day 1 score, there was \>20% increase at any time, decrease \<2 on Day 3, \<20% decrease on Day 4, \<20% decrease on 2 consecutive occasions Days 5-11 or \<50% decrease at follow-up, then criterion for treatment failure (TF) was met. Multiple imputation was used when data was insufficient to assess TF.
Outcome measures
| Measure |
Amoxicillin-clavulanate
n=254 Participants
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
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Placebo
n=256 Participants
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
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|---|---|---|
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The Distribution of Children Experiencing Treatment Failure (TF)
Experienced failure
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76 Participants
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111 Participants
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The Distribution of Children Experiencing Treatment Failure (TF)
Did not experience failure
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178 Participants
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145 Participants
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SECONDARY outcome
Timeframe: Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8.Population: The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible with follow-up post-enrollment.
AOM is an infection of the middle ear marked by acute symptoms and a bulging tympanic membrane. Its diagnosis coincided with receipt of a systemic antibiotic. Systemic antibiotics include Amoxicillin, Amoxicillin-clavulanate, Azithromycin, Bacillin L-A, Cefdinir, Clindamycin, Doxycycline, Levofloxacin, Ofloxacin \& Sulfamethoxazole-Trimethoprim. Start and stop dates were recorded.
Outcome measures
| Measure |
Amoxicillin-clavulanate
n=251 Participants
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
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Placebo
n=256 Participants
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
|
|---|---|---|
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The Distribution of Children Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up
Developed AOM
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0 Participants
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8 Participants
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The Distribution of Children Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up
Did not develop AOM
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251 Participants
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248 Participants
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SECONDARY outcome
Timeframe: Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8.Population: The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible with follow-up post-enrollment.
Systemic antibiotics include Amoxicillin, Amoxicillin-clavulanate, Azithromycin, Bacillin L-A, Cefdinir, Clindamycin, Doxycycline, Levofloxacin, Ofloxacin \& Sulfamethoxazole-Trimethoprim. Start and stop dates were recorded. The antibiotic received is exclusive of the study product assigned at enrollment.
Outcome measures
| Measure |
Amoxicillin-clavulanate
n=251 Participants
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
|
Placebo
n=256 Participants
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
|
|---|---|---|
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The Distribution of Children Receiving a Systemic Antibiotic Over the First 10 Days of Follow-up
Received a systemic antibiotic
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34 Participants
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66 Participants
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The Distribution of Children Receiving a Systemic Antibiotic Over the First 10 Days of Follow-up
Did not receive a systemic antibiotic
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217 Participants
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190 Participants
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SECONDARY outcome
Timeframe: Day 1 through Day 23.Population: The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible
The monitoring of adverse events (AEs), i.e. diarrhea or generalized rash, began on Day 1 (enrollment) and continued through Day 23 (the follow-up visit). Diarrhea was the occurrence of 3 or more watery stools on one day or 2 watery stools on each of 2 consecutive days. Parents recorded in daily diaries, Days 1-11, information regarding the occurrence of diarrhea. Additionally, parents were asked at the follow-up visit if their child had diarrhea while on study product.
Outcome measures
| Measure |
Amoxicillin-clavulanate
n=254 Participants
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
|
Placebo
n=256 Participants
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
|
|---|---|---|
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The Distribution of Children for Whom Diarrhea or Generalized Rash Was Reported
Diarrhea or rash was reported
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31 Participants
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13 Participants
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The Distribution of Children for Whom Diarrhea or Generalized Rash Was Reported
Neither diarrhea nor rash was reported
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223 Participants
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243 Participants
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SECONDARY outcome
Timeframe: Days 1 to 11, where Day 1 is day of enrollmentPopulation: The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible with information sufficient to determine compliance.
Compliance, expressed as a percentage, is the total number of doses taken divided by the total number of expected doses. The child is considered compliant if he/she has received at least 70% of the study medication. The parent completed diaries evenings Days 2-11. The diaries included yes/no questions - (1) did your child take the study medication last night and (2) did your child take the study medication this morning? The total number of doses taken was calculated based on the responses to question (1), and accounted for the dose dispensed at enrollment when enrollment was 1pm or earlier on Day 1. The total of expected doses was determined from the responses to questions (1) and (2), and accounted for scenarios in which the child was taken off the study medication by the clinician. In some cases, due to incomplete diaries the information was insufficient to declare a child either compliant or not compliant.
Outcome measures
| Measure |
Amoxicillin-clavulanate
n=226 Participants
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
|
Placebo
n=234 Participants
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
|
|---|---|---|
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The Distribution of Children Compliant With Study Medication
Compliant, i.e., received at least 70% of the the study medication
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212 Participants
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221 Participants
|
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The Distribution of Children Compliant With Study Medication
Not compliant, i.e., received less than 70% of study medication
|
14 Participants
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13 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: The follow-up visit. The mean number of days from enrollment to the follow-up visit was 13.4.Population: The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible with a nasopharyngeal specimen obtained at the time of the follow-up visit
The nonsusceptible pathogens considered are penicillin-intermediate and penicillin-resistant Streptococcus pneumoniae (SPN) and ß-lactamase-positive Haemophilus influenzae (NTHi). Susceptibility to penicillin was defined as follows: susceptible as a minimum inhibitory concentration (MIC) of \<=0.06 μg/mL; intermediate as an MIC of greater than 0.06 to less than 2 μg/mL; and resistant as an MIC of \>=2 μg/mL. A nasopharyngeal specimen for bacterial culture was obtained at the time of the follow-up visit, occurring between study days 11 and 23.
Outcome measures
| Measure |
Amoxicillin-clavulanate
n=148 Participants
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
|
Placebo
n=152 Participants
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
|
|---|---|---|
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The Distribution of Children With a Nonsusceptible Pathogen at the Follow-up Visit
Nonsusceptible pathogen at the follow-up visit
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19 Participants
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18 Participants
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The Distribution of Children With a Nonsusceptible Pathogen at the Follow-up Visit
No nonsusceptible pathogen at the follow-up visit
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129 Participants
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134 Participants
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Adverse Events
Amoxicillin-clavulanate
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amoxicillin-clavulanate
n=254 participants at risk
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
|
Placebo
n=256 participants at risk
Placebo made to match the study antibiotic (will be taken bid orally for 10 days)
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|---|---|---|
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Gastrointestinal disorders
Diarrhea
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11.4%
29/254 • Number of events 31 • The monitoring of adverse events (AEs) began on Day 1 (enrollment) and continued through Day 23 (the follow-up visit). All recorded AEs were followed to adequate resolution.
Parents recorded in daily diaries, Days 1-11, information regarding the occurrence of diarrhea. Additionally, parents were asked at the follow-up visit if their child had diarrhea while on study product.
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4.7%
12/256 • Number of events 13 • The monitoring of adverse events (AEs) began on Day 1 (enrollment) and continued through Day 23 (the follow-up visit). All recorded AEs were followed to adequate resolution.
Parents recorded in daily diaries, Days 1-11, information regarding the occurrence of diarrhea. Additionally, parents were asked at the follow-up visit if their child had diarrhea while on study product.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place