Trial · NCT02297815
Comparative Effectiveness of Antibiotics for Respiratory Infections
NCT02297815, Completed, Children's Hospital of Philadelphia; results first posted 2017-12-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Effectiveness of Antibiotics for Respiratory Infections. Trials, record NCT02297815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02297815
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Effectiveness of Antibiotics for Respiratory Infections
- NCT number
- NCT02297815
- Status
- Completed
- Enrollment
- 2,472 participants, actual
- Lead sponsor
- Children's Hospital of Philadelphia
- Conditions
- Acute Otitis Media, Acute Sinusitis, Group A Streptococcal Pharyngitis
- Interventions
- Broad-spectrum antibiotics, Narrow-spectrum antibiotics
- First posted
- 2014-11-21
- Last updated
- 2019-07-08
- Results first posted
- 2017-12-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Health Related Quality of Life Score | 5-10 days after ARTI diagnosis | 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. |
| Secondary | Missed School or Daycare From Illness | 5-10 days after ARTI diagnosis | Among children who attend school or daycare, child had to miss school or day care due to illness |
| Secondary | Required Additional Childcare | 5-10 days after ARTI diagnosis | 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. |
| Secondary | Experience Side Effects | 14-20 days after ARTI diagnosis | Child experienced a side effect including: rash, diarrhea or upset stomach/vomiting |
| Secondary | Symptoms Present on Day 3 | 3 days after ARTI diagnosis | 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. |
| Secondary | Sleep Disturbance | Days 5-10 Interview | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Health Related Quality of Life Score | 5-10 days after ARTI diagnosis | 1 subject did not respond to enough of the questions to obtain a score; 41 children missing race and ethnicity were excluded | scores on a scale | GEOMETRIC_MEAN |
| SECONDARY | Missed School or Daycare From Illness | 5-10 days after ARTI diagnosis | Among children who attend school or daycare; 41 children missing race and ethnicity were excluded | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Required Additional Childcare | 5-10 days after ARTI diagnosis | Among children who attend school or daycare; 41 children missing race and ethnicity were excluded | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Experience Side Effects | 14-20 days after ARTI diagnosis | Question was asked in the 14-20 interview so some subjects were lost to follow-up; 41 children missing race and ethnicity were excluded | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Symptoms Present on Day 3 | 3 days after ARTI diagnosis | Among subjects who reported having at least one symptom at the time of diagnosis; 41 children missing race and ethnicity were excluded | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sleep Disturbance | Days 5-10 Interview | 41 children missing race and ethnicity excluded; 1 child did not complete PedsQL | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Health Related Quality of Life Score | Narrow Spectrum Antibiotic | 91.5 | Standard Deviation 9.3 | scores on a scale | |
| Health Related Quality of Life Score | Broad Spectrum Antibiotic | 90.2 | Standard Deviation 10.5 | scores on a scale | |
| Missed School or Daycare From Illness | Narrow Spectrum Antibiotic | 503 | Participants | ||
| Missed School or Daycare From Illness | Broad Spectrum Antibiotic | 305 | Participants | ||
| Required Additional Childcare | Narrow Spectrum Antibiotic | 390 | Participants | ||
| Required Additional Childcare | Non-narrow Spectrum Antibiotic | 220 | Participants | ||
| Experience Side Effects | Narrow Spectrum Antibiotic | 341 | Participants | ||
| Experience Side Effects | Non-narrow Spectrum Antibiotic | 258 | Participants | ||
| Symptoms Present on Day 3 | Narrow Spectrum Antibiotic | 427 | Participants | ||
| Symptoms Present on Day 3 | Non-narrow Spectrum Antibiotic | 267 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Narrow Spectrum Antibiotic | 1,604 | |
| Overall Study | STARTED | Broad-Spectrum Antibiotic | 868 | |
| Overall Study | 5-10 Day Interview | Narrow Spectrum Antibiotic | 1,604 | |
| Overall Study | 5-10 Day Interview | Broad-Spectrum Antibiotic | 868 | |
| Overall Study | 14-20 Day Interview | Narrow Spectrum Antibiotic | 1,368 | |
| Overall Study | 14-20 Day Interview | Broad-Spectrum Antibiotic | 728 | |
| Overall Study | COMPLETED | Narrow Spectrum Antibiotic | 1,368 | |
| Overall Study | COMPLETED | Broad-Spectrum Antibiotic | 728 | |
| Overall Study | NOT COMPLETED | Narrow Spectrum Antibiotic | 236 | |
| Overall Study | NOT COMPLETED | Broad-Spectrum Antibiotic | 140 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | General disorders | Narrow Spectrum Antibiotic | 216 | 1,367 | |
| other | Diarrhea | General disorders | Broad Spectrum Antibiotic | 203 | 726 | |
| other | Rash | General disorders | Narrow Spectrum Antibiotic | 150 | 1,367 | |
| other | Rash | General disorders | Broad Spectrum Antibiotic | 90 | 726 | |
| other | Upset stomach and/or vomiting | General disorders | Narrow Spectrum Antibiotic | 80 | 1,367 | |
| other | Upset stomach and/or vomiting | General disorders | Broad Spectrum Antibiotic | 50 | 726 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Narrow Spectrum Antibiotic | 0 | 1,604 |
| Total, all-cause mortality | Broad Spectrum Antibiotic | 0 | 868 |
| Total, other adverse events | Narrow Spectrum Antibiotic | 345 | 1,367 |
| Total, other adverse events | Broad Spectrum Antibiotic | 258 | 726 |
| Total, serious adverse events | Narrow Spectrum Antibiotic | 0 | 1,604 |
| Total, serious adverse events | Broad Spectrum Antibiotic | 0 | 868 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Narrow Spectrum Antibiotic vs Non-narrow Spectrum Antibiotic: Symptoms Present on Day 3 | Trial comparisons |
| Narrow Spectrum Antibiotic vs Non-narrow Spectrum Antibiotic: Experience Side Effects | Trial comparisons |
| Narrow Spectrum Antibiotic vs Broad-Spectrum Antibiotic: Sleep Disturbance | Trial comparisons |
| Narrow Spectrum Antibiotic vs Broad Spectrum Antibiotic: deaths from any cause | Trial comparisons |
| Narrow Spectrum Antibiotic vs Broad Spectrum Antibiotic: Missed School or Daycare From Illness | Trial comparisons |
| Narrow Spectrum Antibiotic vs Non-narrow Spectrum Antibiotic: Required Additional Childcare | Trial comparisons |
| Narrow Spectrum Antibiotic vs Broad Spectrum Antibiotic: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT02297815/registered