Comparative Effectiveness of Antibiotics for Respiratory Infections



Status:Completed
Conditions:Other Indications, Sinusitis, Infectious Disease, Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Otolaryngology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:Any - 12
Updated:12/10/2017
Start Date:January 2014
End Date:April 2016

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Comparative Effectiveness of Broad vs. Narrow Spectrum Antibiotics for Acute Respiratory Tract Infections in Children

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.

Outpatient, ARTIs account for the vast majority of antibiotic exposure to children, and
roughly half of these antibiotic prescriptions are inappropriate. Although unnecessary
antibiotic prescribing for viral infections has significantly decreased, there has been a
substantial increase in prescribing of broad-spectrum antibiotics to treat ARTIs when
narrow-spectrum antibiotics are indicated. Primary care providers, patients, and caregivers
would benefit from studies assessing the implications of alternate antibiotic regimens for
these common infections. Specifically, it remains unclear if treating common ARTIs with
broad-spectrum antibiotics leads to an improvement in patient outcomes compared to treatment
with narrow-spectrum antibiotics, particularly considering the increasing threat posed by
antimicrobial resistance. Because of the lack of large comparative effectiveness studies with
patient-centered outcomes addressing this issue, professional guidelines and expert
recommendations are conflicting, and, as a result, practice patterns vary considerably.
Therefore, using patient-centered outcomes, we aim to compare narrow-spectrum and
broad-spectrum antibiotics for the treatment of common ARTIs in children. To accomplish this,
we will perform a prospective cohort study of children receiving antibiotics for ARTI across
a comprehensive pediatric healthcare network. We will conduct telephone interviews with
parent's of children who receive antibiotic treatment for an ARTI. We will assess previously
identified patient-centered outcomes included a health-related quality of life measure,
occurrence of side effects, missed school/daycare, parent missed commitments and/or required
additional childcare and symptoms were still present on day 3 after diagnosis.

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
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Jeffrey S Gerber, MD, PhD
Phone: 267-426-8775
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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