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Outpatient Stewardship Program for Antibiotic Overuse in Pediatric Infections (BIOS Trial)

N/A
Waitlist Available
Led By Jeffrey Gerber, MD PhD MSCE
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (up to 36 months prior to randomization) through each of the study periods (up to 27 months of intervention time following intervention initiation)
Awards & highlights
No Placebo-Only Group

Summary

This trialwill examine how to reduce unnecessary antibiotics in pediatric settings to improve health and prevent resistance.

Who is the study for?
This trial is for clinicians who regularly prescribe and care for children aged 6 months to 12 years with acute respiratory tract infections (ARTIs) at participating sites. Children's visits are included unless they have complex chronic conditions or received antibiotics in the last 30 days.
What is being tested?
The BIOS intervention aims to improve antibiotic prescribing practices in pediatric outpatient settings, focusing on reducing unnecessary broad-spectrum antibiotic use for ARTIs. The study will assess how well the strategy works and its acceptability among clinicians.
What are the potential side effects?
Since this trial focuses on stewardship rather than a specific medication, it does not directly involve side effects of interventions. However, improved prescribing may reduce adverse effects associated with inappropriate antibiotic use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (up to 36 months prior to randomization) through each of the study periods (up to 27 months of intervention time following intervention initiation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (up to 36 months prior to randomization) through each of the study periods (up to 27 months of intervention time following intervention initiation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Engagement with intervention
Implementation of the intervention
Rate of antibiotic prescribing for all ARTIs (viral and bacterial)
+1 more
Secondary study objectives
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by geographic location within each practice setting
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by intervention participation status
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by practice setting
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Early InterventionExperimental Treatment1 Intervention
The early intervention arm will begin receiving the intervention in study period 1.
Group II: Delayed Intervention (Control)Experimental Treatment1 Intervention
The delayed intervention (control) arm will begin receiving the intervention in study period 2. They will receive no intervention during period 1.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
729 Previous Clinical Trials
8,469,279 Total Patients Enrolled
American Academy of PediatricsOTHER
44 Previous Clinical Trials
1,070,059 Total Patients Enrolled
University of PennsylvaniaOTHER
2,075 Previous Clinical Trials
42,718,814 Total Patients Enrolled

Media Library

Broad Implementation of Outpatient Stewardship (BIOS) intervention Clinical Trial Eligibility Overview. Trial Name: NCT05127161 — N/A
Acute Respiratory Tract Infection Research Study Groups: Delayed Intervention (Control), Early Intervention
Acute Respiratory Tract Infection Clinical Trial 2023: Broad Implementation of Outpatient Stewardship (BIOS) intervention Highlights & Side Effects. Trial Name: NCT05127161 — N/A
Broad Implementation of Outpatient Stewardship (BIOS) intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05127161 — N/A
~142 spots leftby Apr 2025
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