Comparative Effectiveness of Antibiotics for Respiratory Infections

Acute Otitis Media Clinical Trial

— CEARI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297815
• Other study ID #: 13-010595
• Status: Completed
• Start date: January 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2019
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2472
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Otitis Media
• Acute Sinusitis
• Group A Streptococcal Pharyngitis
• Infection
• Otitis Media
• Pharyngitis
• Respiratory Tract Infections
• Sinusitis

Intervention

Drug:
• Broad-spectrum antibiotics
Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, cefadroxil, cephalexin
• Narrow-spectrum antibiotics
Amoxicillin, Penicillin

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Missed School or Daycare From Illness	Among children who attend school or daycare, child had to miss school or day care due to illness	5-10 days after ARTI diagnosis
Secondary	Required Additional Childcare	Among children who attend school or daycare, parent or another caretaker had to miss work or an obligation due to child's illness OR additional childcare had to be sought for the child.	5-10 days after ARTI diagnosis
Secondary	Experience Side Effects	Child experienced a side effect including: rash, diarrhea or upset stomach/vomiting	14-20 days after ARTI diagnosis
Secondary	Symptoms Present on Day 3	During 5-10 day interview, parents were asked about symptoms related to child's illness (otitis media: fever, ear pain, decreased appetite; sinusitis: fever, face/head pain, decreased appetite; pharyngitis: throat pain, fever, decreased appetite). Parent was asked if symptoms was present at diagnosis. If yes, had the symptom resolved. If yes, when. We assessed whether symptoms present at day 3 after diagnosis.	3 days after ARTI diagnosis
Secondary	Sleep Disturbance	The PedsQL questionnaire includes one or two questions, depending on age, about sleep. For children <24 months, parents are asked the frequency (never, almost never, sometimes, often, almost always) their child has (1) "difficulty falling asleep" and (2) "difficulty sleeping through the night." For children =2 years, parents are asked the frequency their child has "trouble sleeping." We categorized children as either without sleep disturbance ("Never" for each sleep question) or with sleep disturbance. Outcome measure shows the number of participants with sleep disturbance.	Days 5-10 Interview