Comparative Effectiveness of Antibiotics for Respiratory Infections (CEARI)
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|ClinicalTrials.gov Identifier: NCT02297815|
Recruitment Status : Completed
First Posted : November 21, 2014
Results First Posted : December 8, 2017
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment|
|Acute Otitis Media Acute Sinusitis Group A Streptococcal Pharyngitis||Drug: Broad-spectrum antibiotics Drug: Narrow-spectrum antibiotics|
|Study Type :||Observational|
|Actual Enrollment :||2472 participants|
|Official Title:||Comparative Effectiveness of Broad vs. Narrow Spectrum Antibiotics for Acute Respiratory Tract Infections in Children|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Children diagnosed with an acute respiratory tract infections (ARTI) and prescribed Broad-spectrum antibiotics.
Drug: Broad-spectrum antibiotics
Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, cefadroxil, cephalexin
Children diagnosed with an acute respiratory tract infections (ARTI) and prescribed Narrow-spectrum antibiotics.
Drug: Narrow-spectrum antibiotics
- Health Related Quality of Life Score [ Time Frame: 5-10 days after ARTI diagnosis ]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.
- Missed School or Daycare From Illness [ Time Frame: 5-10 days after ARTI diagnosis ]Among children who attend school or daycare, child had to miss school or day care due to illness
- Required Additional Childcare [ Time Frame: 5-10 days after ARTI diagnosis ]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.
- Experience Side Effects [ Time Frame: 14-20 days after ARTI diagnosis ]Child experienced a side effect including: rash, diarrhea or upset stomach/vomiting
- Symptoms Present on Day 3 [ Time Frame: 3 days after ARTI diagnosis ]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.
- Sleep Disturbance [ Time Frame: Days 5-10 Interview ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297815
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Jeffrey S Gerber, MD, PhD||Children's Hospital of Philadelphia|