Outpatient Stewardship Program for Antibiotic Overuse in Pediatric Infections

(BIOS Trial)

Recruiting at 4 trial locations

Overseen By Chloe Hannan, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must not be taking: Antibiotics

Disqualifiers: Complex chronic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1032 Participants Needed

Trial Summary

What is the purpose of this trial?

Reducing inappropriate antibiotic use is a key strategy to mitigate antibiotic resistance and adverse health effects associated with antibiotic exposure. The Broad Implementation of Outpatient Stewardship (BIOS) project focuses on broadly implementing an evidence-based intervention to improve antibiotic prescribing for acute respiratory tract infections in pediatric outpatient settings. Primary aims include: (1) examining the acceptability, feasibility and utility of a focused implementation strategy on improving intervention adoption and impact and (2) measuring the effectiveness of the intervention to reduce unnecessary broad-spectrum antibiotic prescription.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the Outpatient Stewardship Program for Antibiotic Overuse in Pediatric Infections?

Research shows that antimicrobial stewardship programs (efforts to improve how antibiotics are used) in outpatient settings can significantly reduce unnecessary antibiotic prescriptions and bacterial resistance, as seen in a study on urinary tract infections. This suggests that similar programs could be effective for pediatric infections. ^{1 2 3 4 5}

Is the Outpatient Stewardship Program for Antibiotic Overuse in Pediatric Infections safe for children?

The research focuses on improving antibiotic use to prevent antibiotic-resistant infections and avoidable adverse drug events in children, suggesting that the program aims to enhance safety by reducing unnecessary antibiotic use. ^{1 4 6 7 8}

How is the BIOS treatment different from other treatments for pediatric infections?

The BIOS treatment is unique because it focuses on outpatient antimicrobial stewardship, which means it aims to improve how antibiotics are used in community settings to prevent overuse and resistance. Unlike standard treatments that may not address overprescription, BIOS involves a systematic approach to monitor and optimize antibiotic use specifically for children outside of hospitals. ^{1 2 5 9 10}

Research Team

Jeffrey Gerber, MD, PhD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

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.

Inclusion Criteria

I am between 6 months and 12 years old.

Clinician inclusion criteria: Any non-trainee clinician who prescribes and provides care for children aged 6 months to 12 years with ARTIs and who is practicing at an included site. Clinicians will further be selected based on employment status at time of randomization and volume of prescribing over the past 12 months.

Exclusion Criteria

Clinician exclusion criteria: clinicians who are trainees, who do not prescribe (or prescribe very infrequently) to the patient population of interest, or who do not provide care for (or provide care very infrequently for) children aged 6 months to 12 years with ARTIs will be excluded

My child has a complex chronic condition and/or was treated with antibiotics in the last 30 days.

Timeline

Baseline

Baseline period that occurs prior to randomization

Up to 36 months

Early Intervention

Clinicians in the early intervention arm receive the intervention

40 months

Delayed Intervention

Clinicians in the delayed intervention (control) arm begin receiving the intervention

40 months

Maintenance

Maintenance period where external support from the study team is removed

40 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

Treatment Details

Interventions

• Broad Implementation of Outpatient Stewardship (BIOS) intervention

Trial Overview 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.

Participant Groups

Group I: Early Intervention Experimental Treatment 1 Intervention

The early intervention arm will begin receiving the intervention in study period 1.

Group II: Delayed Intervention (Control) Experimental Treatment 1 Intervention

The delayed intervention (control) arm will begin receiving the intervention in study period 2. They will receive no intervention during period 1.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

MetroHealth System, Ohio

Collaborator

Trials

8

Recruited

26,100+

American Academy of Pediatrics

Collaborator

Trials

46

Recruited

4,071,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

The MetroHealth System

Collaborator

Trials

5

Recruited

24,500+

Penn State Health

Collaborator

Trials

2

Recruited

1,200+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Pediatric Associates of Florida

Collaborator

Trials

1

Recruited

1,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Outpatient Pediatric Antibiotic Use: a Systematic Review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Antimicrobial Stewardship in the Pediatric Primary Care Setting. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Outpatient Antibiotic Use and the Need for Increased Antibiotic Stewardship Efforts. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Pediatrician perceptions of an outpatient antimicrobial stewardship intervention. [2014]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of a Primary Care Antimicrobial Stewardship Program on Bacterial Resistance Control and Ecological Imprint in Urinary Tract Infections. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Proposed metrics to benchmark antibiotic prescribing in pediatric outpatient settings. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Targets and Methods to Improve Outpatient Antibiotic Prescribing for Pediatric Patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Decline in oral antimicrobial prescription in the outpatient setting after nationwide implementation of financial incentives and provider education: An interrupted time-series analysis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Outpatient antimicrobial stewardship programs in pediatric institutions in 2020: Status, needs, barriers. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Antibiotic stewardship targets in the outpatient setting. [2020]