Acute Otitis Media Clinical Trial
— CEARIOfficial title:
Comparative Effectiveness of Broad vs. Narrow Spectrum Antibiotics for Acute Respiratory Tract Infections in Children
NCT number | NCT02297815 |
Other study ID # | 13-010595 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | April 2016 |
Verified date | April 2019 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia |
United States,
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 |
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