NCT02297815

Comparative Effectiveness of Antibiotics for Respiratory Infections

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,472 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Acute Otitis Media
• Acute Sinusitis
• Group A Streptococcal Pharyngitis

Interventions

Type	Name	Description
DRUG	Broad-spectrum antibiotics	Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, cefadroxil, cephalexin
DRUG	Narrow-spectrum antibiotics	Amoxicillin, Penicillin

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-11-21
• Last updated: 2019-07-08
• Results posted: 2017-12-08

Locations

1 site across 1 country: United States