Comparative Effectiveness of Antibiotics for Respiratory Infections

NCT02297815 | Completed Results

• 1 other identifier: 13-010595
• Study Type: observational
• Target: 2,472
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Otitis Media; Acute Sinusitis; Group A Streptococcal Pharyngitis

Keywords

antibiotic use; effectiveness; acute respiratory infections; pediatrics

Outcome Measures

Primary Outcomes (1)

• Health Related Quality of Life Score

  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.

  5-10 days after ARTI diagnosis

Secondary Outcomes (5)

• Missed School or Daycare From Illness

  5-10 days after ARTI diagnosis

• Required Additional Childcare

  5-10 days after ARTI diagnosis

• Experience Side Effects

  14-20 days after ARTI diagnosis

• Symptoms Present on Day 3

  3 days after ARTI diagnosis

• Sleep Disturbance

  Days 5-10 Interview

Study Arms (2)

Broad-spectrum antibiotics

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

Drug: Broad-spectrum antibiotics

Narrow-spectrum

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

Drug: Narrow-spectrum antibiotics

Interventions

Broad-spectrum antibiotics DRUG

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

Broad-spectrum antibiotics

Narrow-spectrum antibiotics DRUG

Amoxicillin, Penicillin

Narrow-spectrum

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Child diagnosed with an ARTI and prescribed antibiotics during an outpatient visit in the CHOP primary care network.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr. Jeffrey Gerber
• Organization: Children's Hospital of Philadelphia

gerberj@email.chop.edu

(267) 426-8775

Study Officials

• Jeffrey S Gerber, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 21, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 8, 2019
• Results First Posted: December 8, 2017

Record last verified: 2019-04

Locations

US (1)