Comparative Effectiveness of Antibiotics for Respiratory Infections (CEARI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02297815|
Recruitment Status : Completed
First Posted : November 21, 2014
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
|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|
|Primary Completion Date :||April 2016|
|Study Completion Date :||April 2016|
Children treated for an ARTI
Children diagnosed with an acute respiratory tract infections (ARTI) and prescribed antibiotics.
Drug: Broad-spectrum antibiotics
Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, cefadroxil, cephalexinDrug: 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.
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|