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Trial record 24 of 26 for:    "Sinusitis" | "Clavulanate"

Comparative Effectiveness of Antibiotics for Respiratory Infections (CEARI)

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ClinicalTrials.gov Identifier: NCT02297815
Recruitment Status : Completed
First Posted : November 21, 2014
Results First Posted : December 8, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Acute Otitis Media
Acute Sinusitis
Group A Streptococcal Pharyngitis
Interventions Drug: Broad-spectrum antibiotics
Drug: Narrow-spectrum antibiotics
Enrollment 2472
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Narrow Spectrum Antibiotic Broad-Spectrum Antibiotic
Hide Arm/Group Description Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic Children diagnosed with an ARTI and prescribed a Broad-spectrum antibiotic
Period Title: Overall Study
Started 1604 868
5-10 Day Interview 1604 868
14-20 Day Interview 1368 728
Completed 1368 728
Not Completed 236 140
Reason Not Completed
Lost to Follow-up             236             140
Arm/Group Title Narrow Spectrum Antibiotics Non-narrow Spectrum Antibiotics Total
Hide Arm/Group Description

Child prescribed with the following at time of diagnosis:

Acute otitis media: Amoxicillin Acute sinusitis: Amoxicillin Streptococcal pharyngitis: Penicillin or Amoxicillin

Child prescribed with the following at time of diagnosis:

Acute otitis media: Amoxicillin-Clavulanate, Azithromycin, Cefdinir, Cefprozil, Cefuroxime Axetil Acute sinusitis: Amoxicillin-Clavulanate, Azithromycin, Cefdinir, Cefprozil, Cefuroxime Axetil Streptococcal pharyngitis: Amoxicillin-Clavulanate, Azithromycin, Cefadroxil, Cefdinir, Cefprozil, Cefuroxime Axetil, Cephalexin

Total of all reporting groups
Overall Number of Baseline Participants 1604 868 2472
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1604 participants 868 participants 2472 participants
4.83  (3.51) 5.19  (3.56) 4.96  (3.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1604 participants 868 participants 2472 participants
Female
774
  48.3%
423
  48.7%
1197
  48.4%
Male
830
  51.7%
445
  51.3%
1275
  51.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 1604 participants 868 participants 2472 participants
Latino/hispanic
147
   9.2%
65
   7.5%
212
   8.6%
White (non-latino or unknown ethnicity)
821
  51.2%
630
  72.6%
1451
  58.7%
Black (non-latino or unknown ethnicity)
474
  29.6%
106
  12.2%
580
  23.5%
Other (non-latino/unknown ethnicity)
129
   8.0%
59
   6.8%
188
   7.6%
Unknown race and unknown ethnicity
33
   2.1%
8
   0.9%
41
   1.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1604 participants 868 participants 2472 participants
1604
 100.0%
868
 100.0%
2472
 100.0%
1.Primary Outcome
Title Health Related Quality of Life Score
Hide Description The health related quality of life score was obtained using the PedsQL(TM) (Mapi Research Trust, Lyon, France. www.pedsql.org) Parent-Proxy Report Generic Core Scales and Parent Report Infant Scales administered during the 5-10 day interview. Briefly, the PedsQL(TM) is a 23-item questionnaire assessing developmentally appropriate metrics (questions vary by age group: 1-12 months, 13-24 months, 2-4 years, 5-7 years, 8-12 years) related to core dimensions of health and role functioning. Our primary outcome was the Total Scale Score, which is a summary score of physical, emotional, social, and school functioning. The score range is zero to 100 and higher scores indicate a better health-related quality of life.
Time Frame 5-10 days after ARTI diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
1 subject did not respond to enough of the questions to obtain a score; 41 children missing race and ethnicity were excluded
Arm/Group Title Narrow Spectrum Antibiotic Broad Spectrum Antibiotic
Hide Arm/Group Description:
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
Overall Number of Participants Analyzed 1570 860
Geometric Mean (Standard Deviation)
Unit of Measure: scores on a scale
91.5  (9.3) 90.2  (10.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narrow Spectrum Antibiotic, Broad Spectrum Antibiotic
Comments Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted linear regression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Weighted linear regression
Comments Propensity-score based full matching performed. Average treatment effect weights calculated and applied to a weighted linear regression.
Method of Estimation Estimation Parameter Score difference
Estimated Value -1.40
Confidence Interval (2-Sided) 95%
-2.44 to -0.36
Estimation Comments Narrow antibiotics is the reference group. A score difference less than zero indicates that broad spectrum antibiotics are associated with a lower (poorer) health related quality of life score.
2.Secondary Outcome
Title Missed School or Daycare From Illness
Hide Description Among children who attend school or daycare, child had to miss school or day care due to illness
Time Frame 5-10 days after ARTI diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
Among children who attend school or daycare; 41 children missing race and ethnicity were excluded
Arm/Group Title Narrow Spectrum Antibiotic Broad Spectrum Antibiotic
Hide Arm/Group Description:
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
Overall Number of Participants Analyzed 1199 702
Measure Type: Count of Participants
Unit of Measure: Participants
503
  42.0%
305
  43.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narrow Spectrum Antibiotic, Broad Spectrum Antibiotic
Comments Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Weighted logistic regression
Comments Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-3.1 to 7.9
Estimation Comments Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome
3.Secondary Outcome
Title Required Additional Childcare
Hide Description Among children who attend school or daycare, parent or another caretaker had to miss work or an obligation due to child's illness OR additional childcare had to be sought for the child.
Time Frame 5-10 days after ARTI diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
Among children who attend school or daycare; 41 children missing race and ethnicity were excluded
Arm/Group Title Narrow Spectrum Antibiotic Non-narrow Spectrum Antibiotic
Hide Arm/Group Description:
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
Children diagnosed with an ARTI and prescribed a non-narrow spectrum antibiotic
Overall Number of Participants Analyzed 1190 701
Measure Type: Count of Participants
Unit of Measure: Participants
390
  32.8%
220
  31.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narrow Spectrum Antibiotic, Non-narrow Spectrum Antibiotic
Comments Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Weighted logistic regression
Comments Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
-3.9 to 6.8
Estimation Comments Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome
4.Secondary Outcome
Title Experience Side Effects
Hide Description Child experienced a side effect including: rash, diarrhea or upset stomach/vomiting
Time Frame 14-20 days after ARTI diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
Question was asked in the 14-20 interview so some subjects were lost to follow-up; 41 children missing race and ethnicity were excluded
Arm/Group Title Narrow Spectrum Antibiotic Non-narrow Spectrum Antibiotic
Hide Arm/Group Description:
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
Children diagnosed with an ARTI and prescribed a non-narrow spectrum antibiotic
Overall Number of Participants Analyzed 1360 725
Measure Type: Count of Participants
Unit of Measure: Participants
341
  25.1%
258
  35.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narrow Spectrum Antibiotic, Non-narrow Spectrum Antibiotic
Comments Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Weighted logistic regression
Comments Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.2
Confidence Interval (2-Sided) 95%
7.3 to 17.2
Estimation Comments Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome
5.Secondary Outcome
Title Symptoms Present on Day 3
Hide Description During 5-10 day interview, parents were asked about symptoms related to child's illness (otitis media: fever, ear pain, decreased appetite; sinusitis: fever, face/head pain, decreased appetite; pharyngitis: throat pain, fever, decreased appetite). Parent was asked if symptoms was present at diagnosis. If yes, had the symptom resolved. If yes, when. We assessed whether symptoms present at day 3 after diagnosis.
Time Frame 3 days after ARTI diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
Among subjects who reported having at least one symptom at the time of diagnosis; 41 children missing race and ethnicity were excluded
Arm/Group Title Narrow Spectrum Antibiotic Non-narrow Spectrum Antibiotic
Hide Arm/Group Description:
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
Children diagnosed with an ARTI and prescribed a non-narrow spectrum antibiotic
Overall Number of Participants Analyzed 1128 647
Measure Type: Count of Participants
Unit of Measure: Participants
427
  37.9%
267
  41.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narrow Spectrum Antibiotic, Non-narrow Spectrum Antibiotic
Comments Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Weighted logistic regression
Comments Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
-0.8 to 10.6
Estimation Comments Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome
6.Secondary Outcome
Title Sleep Disturbance
Hide Description The PedsQL questionnaire includes one or two questions, depending on age, about sleep. For children <24 months, parents are asked the frequency (never, almost never, sometimes, often, almost always) their child has (1) “difficulty falling asleep” and (2) “difficulty sleeping through the night.” For children ≥2 years, parents are asked the frequency their child has “trouble sleeping.” We categorized children as either without sleep disturbance (“Never” for each sleep question) or with sleep disturbance. Outcome measure shows the number of participants with sleep disturbance.
Time Frame Days 5-10 Interview
Hide Outcome Measure Data
Hide Analysis Population Description
41 children missing race and ethnicity excluded; 1 child did not complete PedsQL
Arm/Group Title Narrow Spectrum Antibiotic Broad-Spectrum Antibiotic
Hide Arm/Group Description:
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
Children diagnosed with an ARTI and prescribed a Broad-spectrum antibiotic
Overall Number of Participants Analyzed 1570 860
Measure Type: Count of Participants
Unit of Measure: Participants
582
  37.1%
378
  44.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narrow Spectrum Antibiotic, Broad-Spectrum Antibiotic
Comments Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Weighted logistic regression
Comments Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
-0.3 to 9.6
Estimation Comments Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome
Time Frame Up to 20 days from ARTI diagnosis
Adverse Event Reporting Description Adverse events were assessed at the interview that occurred between day 14 and day 20 after diagnosis. Subjects with missing data due to incomplete interviews or withdrawal/loss to follow-up prior to that interview are not included. All-cause mortality and SAEs could be determined for all subjects via reviews of electronic health records.
 
Arm/Group Title Narrow Spectrum Antibiotic Broad Spectrum Antibiotic
Hide Arm/Group Description Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
All-Cause Mortality
Narrow Spectrum Antibiotic Broad Spectrum Antibiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1604 (0.00%)   0/868 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Narrow Spectrum Antibiotic Broad Spectrum Antibiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1604 (0.00%)   0/868 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Narrow Spectrum Antibiotic Broad Spectrum Antibiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   345/1367 (25.24%)   258/726 (35.54%) 
General disorders     
Diarrhea   216/1367 (15.80%)  203/726 (27.96%) 
Rash   150/1367 (10.97%)  90/726 (12.40%) 
Upset stomach and/or vomiting   80/1367 (5.85%)  50/726 (6.89%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jeffrey Gerber
Organization: Children's Hospital of Philadelphia
Phone: (267) 426-8775
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02297815     History of Changes
Other Study ID Numbers: 13-010595
First Submitted: November 17, 2014
First Posted: November 21, 2014
Results First Submitted: December 20, 2016
Results First Posted: December 8, 2017
Last Update Posted: July 8, 2019