Comparative Effectiveness of Antibiotics for Respiratory Infections

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2472 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Otitis Media Acute Sinusitis Group A Streptococcal Pharyngitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Broad-spectrum antibiotics

Children diagnosed with an acute respiratory tract infections (ARTI) and prescribed Broad-spectrum antibiotics.

Broad-spectrum antibiotics

Intervention Type DRUG

Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, cefadroxil, cephalexin

Narrow-spectrum

Children diagnosed with an acute respiratory tract infections (ARTI) and prescribed Narrow-spectrum antibiotics.

Narrow-spectrum antibiotics

Intervention Type DRUG

Amoxicillin, Penicillin

Interventions

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Broad-spectrum antibiotics

Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, cefadroxil, cephalexin

Intervention Type DRUG

Narrow-spectrum antibiotics

Amoxicillin, Penicillin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No