Comparative Effectiveness of Antibiotics for Respiratory Infections

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02297815
Study type	Observational
Source	Children's Hospital of Philadelphia
Contact
Status	Completed
Phase
Start date	January 2014
Completion date	April 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02092454` - Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media	Phase 2
Completed	`NCT01202578` - Evaluation of the Tympanostomy Tube Delivery System	Phase 2/Phase 3
Withdrawn	`NCT00502450` - Is There Hearing Loss After Acute Mastoiditis	N/A
Completed	`NCT04296448` - Evaluation of Cellphone Based Otoscopy in Pediatric Patients	N/A
Terminated	`NCT05651633` - Analgesic Ear Drops for Children With Acute Otitis Media	Phase 3
Completed	`NCT02345447` - Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence	Phase 3
Completed	`NCT01941381` - Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?
Recruiting	`NCT01214538` - Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children	N/A
Completed	`NCT03614117` - Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR)	N/A
Recruiting	`NCT06027593` - Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions	N/A
Completed	`NCT02918773` - Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)	N/A
Completed	`NCT02567747` - Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
Completed	`NCT02935374` - Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children	Phase 4
Completed	`NCT02567825` - Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media	N/A
Completed	`NCT02037893` - Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media	Phase 2
Completed	`NCT00578773` - A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea	Phase 2
Completed	`NCT00377260` - Acute Otitis Media (AOM) Therapy Trial in Young Children	Phase 4
Completed	`NCT00645112` - A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media	Phase 4
Completed	`NCT00368823` - A Trial of Point of Care Information in Ambulatory Pediatrics	Phase 3
Completed	`NCT01272999` - Impact of Prevnar 13 on Ear Infections in Children

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparative Effectiveness of Antibiotics for Respiratory Infections — CEARI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms