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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

BIOS Trial 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.Check my eligibility

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.See study design

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.

BIOS Trial Timeline

Screening ~ 3 weeks3 visits

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)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Engagement with intervention

Implementation of the intervention

Rate of antibiotic prescribing for all ARTIs (viral and bacterial)

+1 more

Secondary outcome measures

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

BIOS 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,580,271 Total Patients Enrolled

American Academy of PediatricsOTHER

40 Previous Clinical Trials

1,015,436 Total Patients Enrolled

University of PennsylvaniaOTHER

2,000 Previous Clinical Trials

42,879,056 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate goal of this experiment?

"This clinical trial seeks to assess the implementation of a particular intervention over 36 months before randomization, and 27 months following its initiation. Secondary outcome measures include rate of broad-spectrum antibiotic prescribing by practice setting, rate of antibiotic prescribing for all ARTIs (both viral and bacterial), as well as rate of antibiotic prescription for only those ARTIs caused by viruses which would not require antibiotics by practice setting."

Answered by AI

In what geographic regions is this investigation accessible?

"This research project is currently being carried out at 5 distinct sites, including Plantation and Philadelphia. To reduce potential inconveniences, it may be beneficial for patients to select the nearest location."

Answered by AI

What type of subjects is this experiment best suited for?

"Eligibility requirements for this trial necessitate that participants possess sinusitis and fall within the 6 month to 12 year old age range. Up to 936 people are eligible to partake in the study."

Answered by AI

Is there an upper age limit to be qualified for this investigation?

"This clinical trial requires participants aged 6 months to 12 years in order to meet the respective eligibility parameters."

Answered by AI

Are additional participants being accepted for this investigation?

"According to clinicaltrials.gov, the recruitment period for this trial concluded on November 8th 2022. Nevertheless, there are currently 165 other studies actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Broad Implementation of Outpatient Stewardship

2022. "Broad Implementation of Outpatient Stewardship". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05127161.