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Trial record 25 of 26 for:    sinusitis AND Clavulanate

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 : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment
Acute Otitis Media Acute Sinusitis Group A Streptococcal Pharyngitis Drug: Broad-spectrum antibiotics Drug: Narrow-spectrum antibiotics

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.

Study Type : Observational
Actual Enrollment : 2472 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
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, cephalexin

Drug: Narrow-spectrum antibiotics
Amoxicillin, Penicillin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Experience Side Effects [ Time Frame: 14-20 days after ARTI diagnosis ]
    Child experienced a side effect including: rash, diarrhea or upset stomach/vomiting

  4. 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.



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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Child diagnosed with an ARTI and prescribed antibiotics during an outpatient visit in the CHOP primary care network.
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

Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Jeffrey S Gerber, MD, PhD Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02297815     History of Changes
Other Study ID Numbers: 13-010595
First Posted: November 21, 2014    Key Record Dates
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017
Last Verified: August 2017

Keywords provided by Children's Hospital of Philadelphia:
antibiotic use
effectiveness
acute respiratory infections
pediatrics

Additional relevant MeSH terms:
Sinusitis
Infection
Respiratory Tract Infections
Otitis Media
Pharyngitis
Respiratory Tract Diseases
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Nose Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents