Outpatient Stewardship Program for Antibiotic Overuse in Pediatric Infections

(BIOS Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce the overuse of antibiotics in children with common respiratory infections. It evaluates whether the Broad Implementation of Outpatient Stewardship (BIOS) intervention helps doctors prescribe antibiotics more appropriately, potentially preventing antibiotic resistance and other health issues. The study divides participants into two groups: one receives the intervention early, and the other receives it later. Families with children aged 6 months to 12 years visiting participating clinics can participate, especially if their children frequently experience respiratory infections. As an unphased trial, this study offers families the opportunity to contribute to important research that could enhance antibiotic use in children.

Will I have to stop taking my current medications?

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

What prior data suggests that the BIOS intervention is safe for pediatric use?

Research shows that the Broad Implementation of Outpatient Stewardship (BIOS) program aims to improve antibiotic prescribing for children with respiratory infections. Studies have found that excessive use of broad-spectrum antibiotics can lead to antibiotic resistance and harmful side effects. The BIOS program seeks to reduce this overuse by promoting better antibiotic practices.

The BIOS program focuses on changing how doctors prescribe antibiotics, not on introducing a new drug. Therefore, it avoids the usual safety concerns associated with testing new medications. Instead, it aims for safer, more effective use of existing treatments. This approach is generally well-received because it involves education and guidelines rather than new substances.

In summary, the BIOS program promotes wiser antibiotic use to avoid unnecessary side effects and combat resistance. It does not test a new drug, so traditional safety concerns are minimal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Outpatient Stewardship Program for Antibiotic Overuse in Pediatric Infections because it's tackling the overuse of antibiotics in children in a fresh way. Unlike standard treatments that focus primarily on prescribing the right antibiotic, this program aims to change how and when antibiotics are prescribed in the first place. The Broad Implementation of Outpatient Stewardship (BIOS) intervention is designed to educate and guide healthcare providers on better antibiotic practices, potentially reducing unnecessary use and helping combat antibiotic resistance. This shift from just treating infections to preventing unnecessary treatment is what makes this approach stand out.

What evidence suggests that the BIOS intervention is effective for reducing unnecessary antibiotic prescriptions in pediatric infections?

Research shows that using fewer broad-spectrum antibiotics can help fight antibiotic resistance and reduce side effects. Studies have found that improving antibiotic prescription practices can significantly decrease unnecessary use in children with respiratory infections. This trial tests the BIOS program, which teaches doctors to prescribe antibiotics only when necessary, preventing overuse. Participants in the early intervention arm will receive the BIOS intervention in study period 1, while those in the delayed intervention (control) arm will start in study period 2. This approach aims to improve health outcomes and lower the risk of developing resistant bacteria. Early results suggest that programs like BIOS are promising for managing antibiotic use in children's healthcare. ^{1 2 3 4 6}

Who Is on the Research Team?

Jeffrey Gerber, MD, PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05127161?term=AREA%5BConditionSearch%5D(Respiratory%20Tract%20Infections)%20AND%20AREA%5BBasicSearch%5D(Gerber,%20Jeffrey)&rank=2

Broad Implementation of Outpatient Stewardship (BIOS) Overuse of broad-spectrum antibiotics can exacerbate antibiotic resistance and drug-related adverse events. Certain interventions have been effective in ...

2. clinicaltrial.be clinicaltrial.be/en/details/176117?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

Broad Implementation of Outpatient Stewardship Overuse of broad-spectrum antibiotics can exacerbate antibiotic resistance and drug-related adverse events. Certain interventions have been ...

3. ctv.veeva.com ctv.veeva.com/study/broad-implementation-of-outpatient-stewardship

Broad Implementation of Outpatient Stewardship (BIOS) Overuse of broad-spectrum antibiotics can exacerbate antibiotic resistance and drug-related adverse events. Certain interventions have been ...

4. withpower.com withpower.com/trial/outpatient-stewardship-program-for-antibiotic-overuse-in-pediatric-infections-f000a

Outpatient Stewardship Program for Antibiotic Overuse in ... What data supports the effectiveness of the Outpatient Stewardship Program for Antibiotic Overuse in Pediatric Infections? Research shows that antimicrobial ...

5. clinicalfutures.research.chop.edu clinicalfutures.research.chop.edu/infectious-diseasesuse-antibiotics/antibiotic-stewardship-research

Antibiotic Stewardship Research - Clinical Futures They recognized antibiotic overuse as a problem, but believed it was driven by the behaviors of non-pediatric physicians. Parent pressure for antibiotics was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6942341/

Implementation and impact of pediatric antimicrobial ... Antibiotic misuse increases the risk of toxicity, raises healthcare costs, and selection of resistance. The primary aim of this systematic review is to ...