N/A
N=2,472
Comparative Effectiveness of Antibiotics for Respiratory Infections
Acute Otitis Media · Acute Sinusitis · Group A Streptococcal Pharyngitis
Bottom Line
View on ClinicalTrials.gov: NCT02297815 ↗Enrolled (actual)
2,472
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Health Related Quality of Life Score — 91.5; 90.2 scores on a scale — p=0.008
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Broad-spectrum antibiotics (Drug); Narrow-spectrum antibiotics (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health Related Quality of Life Score |
91.5; 90.2 | 0.008 sig |
| SECONDARY Missed School or Daycare From Illness |
503; 305 | 0.39 |
| SECONDARY Required Additional Childcare |
390; 220 | 0.59 |
| SECONDARY Experience Side Effects |
341; 258 | <0.001 sig |
| SECONDARY Symptoms Present on Day 3 |
427; 267 | 0.09 |
| SECONDARY Sleep Disturbance |
582; 378 | 0.07 |
Summary
The purpose of this study is to identify and use patient centered outcomes to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory tract infections (ARTIs) in children.
Eligibility Criteria
Inclusion Criteria
We included children between six months and 12 years old, diagnosed with an ARTI (acute otitis media, acute sinusitis, Group A streptococcal [GAS] pharyngitis) using International Classification of Diseases diagnosis codes and prescribed an antibiotic. For GAS pharyngitis, the child also had a positive rapid streptococcal test.
Exclusion Criteria
- Diagnosed with multiple ARTIs
- Diagnosed with another non-ARTI bacterial infection
- Prescribe antibiotics in the past 30 days
- Non-English speaking families
- If GAS pharyngitis diagnosis, age < 3 years
Data sourced from ClinicalTrials.gov (NCT02297815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.