Clinical trial NCT02297815: Comparative Effectiveness of Antibiotics for Respiratory Infections
Official title: Comparative Effectiveness of Broad vs. Narrow Spectrum Antibiotics for Acute Respiratory Tract Infections in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Otitis Media
Acute Sinusitis
Group A Streptococcal Pharyngitis
Keywords: antibiotic use
effectiveness
acute respiratory infections
pediatrics
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 2472
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Child diagnosed with an ARTI and prescribed antibiotics during an outpatient visit in the CHOP primary care network.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health Related Quality of Life Score
timeFrame: 5-10 days after ARTI diagnosis
Secondary outcomes:
measure: Missed School or Daycare From Illness
timeFrame: 5-10 days after ARTI diagnosis
measure: Required Additional Childcare
timeFrame: 5-10 days after ARTI diagnosis
measure: Experience Side Effects
timeFrame: 14-20 days after ARTI diagnosis
measure: Symptoms Present on Day 3
timeFrame: 3 days after ARTI diagnosis
measure: Sleep Disturbance
timeFrame: Days 5-10 Interview
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jeffrey S Gerber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: