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Comparative Effectiveness of Antibiotics for Respiratory Infections (CEARI)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02297815
First Posted: November 21, 2014
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
  Purpose
The purpose of this study is to identify and use patient centered outcomes to compare rates of treatment failure and the rate of adverse drug effects between narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory tract infections (ARTIs) in children.

Condition Intervention
Acute Otitis Media Acute Sinusitis Group A Streptococcal Pharyngitis Drug: Broad-spectrum antibiotics AOM: Drug: Broad spectrum antibiotics acute sinusitis Drug: Broad spectrum antibiotics GAS pharyngitis Drug: Narrow spectrum antibiotics AOM Drug: Narrow spectrum antibiotics GAS pharyngitis Drug: Narrow spectrum antibiotics acute sinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness of Broad vs. Narrow Spectrum Antibiotics for Acute Respiratory Tract Infections in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Treatment failure rates [ Time Frame: 14 days after diagnosis of ARTI ]
    Compares treatment failure rates between broad-spectrum and narrow spectrum antibiotics for the treatment of common acute respiratory tract infections in children using patient-centered outcomes.

  • Rate of adverse drug effects [ Time Frame: 14 days after diagnosis of ARTI ]
    Compares the rate of adverse drug effects between broad-spectrum and narrow spectrum antibiotics for the treatment of common acute respiratory tract infections in children using patient-centered outcomes.


Enrollment: 66590
Study Start Date: January 2014
Estimated Study Completion Date: July 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acute otitis media (AOM) Drug: Broad-spectrum antibiotics AOM:
Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, or ceftriaxone
Drug: Narrow spectrum antibiotics AOM
Amoxicillin
Group A streptococcal (GAS) pharyngitis Drug: Broad spectrum antibiotics GAS pharyngitis
Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, cephalexin, ceftriaxone, or sodium cefadroxil
Drug: Narrow spectrum antibiotics GAS pharyngitis
Amoxicillin or penicillin
Acute sinusitis Drug: Broad spectrum antibiotics acute sinusitis
Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil or ceftriaxone
Drug: Narrow spectrum antibiotics acute sinusitis
Amoxicillin

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. Furthermore, the adverse effects of antibiotic use have not been clearly defined or quantified in children. Therefore, using patient-centered outcomes, we aim to: 1) compare treatment failure rates and 2) compare the rate of adverse drug effects between 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. Outcomes will include clinical treatment failure and adverse drug effects as identified by 1) return to primary care, emergency department visits, and hospitalizations for new antibiotic prescription and/or ARTI complication and 2) parent/caregiver assessment of clinical improvement and adverse drug effects. Comparing the patient-specific outcomes between these different antibiotic regimens for ARTIs will help inform treating clinicians and parents of the risks and benefits associated with the management of these common conditions.
  Eligibility

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Visits of all patients who are seen at the CHOP Primary Care Network practices will be identified to estimate the effectiveness and safety of antibiotics for acute respiratory tract infections (ARTIs), while a stratified sample will be used to study additional patient-oriented outcomes.
Criteria

Inclusion Criteria:

  • All acute visits to a practice within the CHOP Network from November 2014 through April 2016 resulting in an International Classification of Diseases, Ninth Revision code (ICD-9) for AOM, sinusitis, or GAS pharyngitis and receipt of an antibiotic.

Exclusion Criteria:

  • Non-English speaking families
  • Children<6 months or >18 years of age
  Contacts and Locations
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
  More Information

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02297815     History of Changes
Other Study ID Numbers: 13-010595
First Submitted: November 17, 2014
First Posted: November 21, 2014
Last Update Posted: October 12, 2017
Last Verified: November 2016

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

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