Trial Outcomes & Findings for Comparative Effectiveness of Antibiotics for Respiratory Infections (NCT NCT02297815)
NCT ID: NCT02297815
Last Updated: 2019-07-08
Results Overview
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.
COMPLETED
2472 participants
5-10 days after ARTI diagnosis
2019-07-08
Participant Flow
Participant milestones
| Measure |
Narrow Spectrum Antibiotic
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
|
Broad-Spectrum Antibiotic
Children diagnosed with an ARTI and prescribed a Broad-spectrum antibiotic
|
|---|---|---|
|
Overall Study
STARTED
|
1604
|
868
|
|
Overall Study
5-10 Day Interview
|
1604
|
868
|
|
Overall Study
14-20 Day Interview
|
1368
|
728
|
|
Overall Study
COMPLETED
|
1368
|
728
|
|
Overall Study
NOT COMPLETED
|
236
|
140
|
Reasons for withdrawal
| Measure |
Narrow Spectrum Antibiotic
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
|
Broad-Spectrum Antibiotic
Children diagnosed with an ARTI and prescribed a Broad-spectrum antibiotic
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
236
|
140
|
Baseline Characteristics
Comparative Effectiveness of Antibiotics for Respiratory Infections
Baseline characteristics by cohort
| Measure |
Narrow Spectrum Antibiotics
n=1604 Participants
Child prescribed with the following at time of diagnosis:
Acute otitis media: Amoxicillin Acute sinusitis: Amoxicillin Streptococcal pharyngitis: Penicillin or Amoxicillin
|
Non-narrow Spectrum Antibiotics
n=868 Participants
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
n=2472 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.83 Years
STANDARD_DEVIATION 3.51 • n=99 Participants
|
5.19 Years
STANDARD_DEVIATION 3.56 • n=107 Participants
|
4.96 Years
STANDARD_DEVIATION 3.53 • n=206 Participants
|
|
Sex: Female, Male
Female
|
774 Participants
n=99 Participants
|
423 Participants
n=107 Participants
|
1197 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
830 Participants
n=99 Participants
|
445 Participants
n=107 Participants
|
1275 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Latino/hispanic
|
147 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
212 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White (non-latino or unknown ethnicity)
|
821 Participants
n=99 Participants
|
630 Participants
n=107 Participants
|
1451 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black (non-latino or unknown ethnicity)
|
474 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
580 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other (non-latino/unknown ethnicity)
|
129 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
188 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown race and unknown ethnicity
|
33 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1604 Participants
n=99 Participants
|
868 Participants
n=107 Participants
|
2472 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5-10 days after ARTI diagnosisPopulation: 1 subject did not respond to enough of the questions to obtain a score; 41 children missing race and ethnicity were excluded
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.
Outcome measures
| Measure |
Narrow Spectrum Antibiotic
n=1570 Participants
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
|
Broad Spectrum Antibiotic
n=860 Participants
Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
|
|---|---|---|
|
Health Related Quality of Life Score
|
91.5 scores on a scale
Standard Deviation 9.3
|
90.2 scores on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 5-10 days after ARTI diagnosisPopulation: Among children who attend school or daycare; 41 children missing race and ethnicity were excluded
Among children who attend school or daycare, child had to miss school or day care due to illness
Outcome measures
| Measure |
Narrow Spectrum Antibiotic
n=1199 Participants
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
|
Broad Spectrum Antibiotic
n=702 Participants
Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
|
|---|---|---|
|
Missed School or Daycare From Illness
|
503 Participants
|
305 Participants
|
SECONDARY outcome
Timeframe: 5-10 days after ARTI diagnosisPopulation: Among children who attend school or daycare; 41 children missing race and ethnicity were excluded
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.
Outcome measures
| Measure |
Narrow Spectrum Antibiotic
n=1190 Participants
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
|
Broad Spectrum Antibiotic
n=701 Participants
Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
|
|---|---|---|
|
Required Additional Childcare
|
390 Participants
|
220 Participants
|
SECONDARY outcome
Timeframe: 14-20 days after ARTI diagnosisPopulation: Question was asked in the 14-20 interview so some subjects were lost to follow-up; 41 children missing race and ethnicity were excluded
Child experienced a side effect including: rash, diarrhea or upset stomach/vomiting
Outcome measures
| Measure |
Narrow Spectrum Antibiotic
n=1360 Participants
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
|
Broad Spectrum Antibiotic
n=725 Participants
Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
|
|---|---|---|
|
Experience Side Effects
|
341 Participants
|
258 Participants
|
SECONDARY outcome
Timeframe: 3 days after ARTI diagnosisPopulation: Among subjects who reported having at least one symptom at the time of diagnosis; 41 children missing race and ethnicity were excluded
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.
Outcome measures
| Measure |
Narrow Spectrum Antibiotic
n=1128 Participants
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
|
Broad Spectrum Antibiotic
n=647 Participants
Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
|
|---|---|---|
|
Symptoms Present on Day 3
|
427 Participants
|
267 Participants
|
SECONDARY outcome
Timeframe: Days 5-10 InterviewPopulation: 41 children missing race and ethnicity excluded; 1 child did not complete PedsQL
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.
Outcome measures
| Measure |
Narrow Spectrum Antibiotic
n=1570 Participants
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
|
Broad Spectrum Antibiotic
n=860 Participants
Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
|
|---|---|---|
|
Sleep Disturbance
|
582 Participants
|
378 Participants
|
Adverse Events
Narrow Spectrum Antibiotic
Broad Spectrum Antibiotic
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Narrow Spectrum Antibiotic
n=1367 participants at risk；n=1604 participants at risk
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic
|
Broad Spectrum Antibiotic
n=726 participants at risk；n=868 participants at risk
Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic
|
|---|---|---|
|
General disorders
Diarrhea
|
15.8%
216/1367 • Up to 20 days from ARTI diagnosis
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.
|
28.0%
203/726 • Up to 20 days from ARTI diagnosis
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.
|
|
General disorders
Rash
|
11.0%
150/1367 • Up to 20 days from ARTI diagnosis
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.
|
12.4%
90/726 • Up to 20 days from ARTI diagnosis
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.
|
|
General disorders
Upset stomach and/or vomiting
|
5.9%
80/1367 • Up to 20 days from ARTI diagnosis
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.
|
6.9%
50/726 • Up to 20 days from ARTI diagnosis
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.
|
Additional Information
Dr. Jeffrey Gerber
Children's Hospital of Philadelphia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place