Acute Respiratory Tract InfectionBIOSNCT05127161
Broad Implementation of Outpatient Stewardship
A study testing Broad Implementation of Outpatient Stewardship (BIOS) intervention in people with Acute Respiratory Tract Infection and Otitis Media, run by Children's Hospital of Philadelphia at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Tract Infection, Otitis Media, Pharyngitis
- What is being tested?
- Broad Implementation of Outpatient Stewardship (BIOS) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,032 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Oct 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- Visit inclusion criteria: visits made by patients of all participating practices aged 6 months through 12 years of age will be considered part of the project population.
Who cannot join
- 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
- Visit exclusion criteria: visit by children with complex chronic conditions, as well as those treated with an antibiotic in the past 30 days, will have their data extracted but will be excluded from analyses
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Nationwide Children's Hospital
Cleveland, Ohio, 43205
MetroHealth
Cleveland, Ohio, 44109
Penn State Health
Hershey, Pennsylvania, 17033
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Pediatric Associates
Plantation, Florida, 33324
About this study
Official title: Broad Implementation of Outpatient Stewardship (BIOS) Project
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.
Read the detailed description
Antibiotics are commonly prescribed for acute respiratory tract infections (ARTIs) in pediatric outpatient settings, but up to half of antibiotic use is inappropriate. Prior work demonstrated broad-spectrum antibiotics did not improve patient health outcomes compared to narrow-spectrum antibiotics, but did increase harmful side effects. Overuse of broad-spectrum antibiotics can exacerbate antibiotic resistance and drug-related adverse events. Certain interventions have been effective in improving antibiotic prescribing, but none have been implemented widely.
The BIOS project focuses on broadly implementing an evidence-based intervention to improve how clinicians in outpatient settings prescribe antibiotics for ARTIs in children 6 months to 12 years old. The intervention consists of educational modules and prescribing audit and feedback reports delivered to clinicians in a variety of outpatient settings across 5 health systems.
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.
Clinicians will be randomized to one of two arms: an early intervention arm or a delayed intervention (control) arm. The study will use a 4-period design, where the periods are as follows:
Period 0: Baseline period that occurs prior to randomization
Period 1: clinicians in the early intervention arm receive the intervention
Period 2: All clinicians (both arms) receive the intervention
Period 3: Maintenance period, external support from the study team is removed
- Being tested
- Broad Implementation of Outpatient Stewardship (BIOS) intervention
- Keywords
- Pediatrics, Outpatient antibiotic stewardship, Broad-spectrum antibiotics
- Medical subject headings
- Otitis Media, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broad Implementation of Outpatient Stewardship (BIOS) interventionBehavioural
The BIOS intervention consists of 3 components: (1) online educational modules covering topics related to appropriate antibiotic prescribing for ARTIs, (2) individualized audit and feedback reports displaying clinicians' rates of antibiotic prescription with peer comparison, (3) facilitation provided by the study team and by health system champions to support effective implementation of the intervention and to encourage clinicians to engage meaningfully in the intervention activities.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention | Experimental | The early intervention arm will begin receiving the intervention in study period 1. Receives: Behavioral: Broad Implementation of Outpatient Stewardship (BIOS) intervention |
| Delayed Intervention (Control) | Other | The delayed intervention (control) arm will begin receiving the intervention in study period 2. They will receive no intervention during period 1. Receives: Behavioral: Broad Implementation of Outpatient Stewardship (BIOS) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of broad-spectrum (off-guideline) antibiotic prescribing for all bacterial ARTIs
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed. Assessed using electronic health record data.
Measured: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of antibiotic prescribing for all ARTIs (viral and bacterial)
The proportion of visits for all ARTIs (viral and bacterial) during which an antibiotic was prescribed
Measured: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Engagement with intervention
Investigators will measure clinicians' completion rates of the educational modules and view rates of the feedback reports. Assessed through clinician attestation.
Measured: Period 1 through period 3 (up to 40 months of intervention time following intervention initiation)
Implementation of the intervention
Investigators will use surveys and qualitative interviews to measure the extent to which the intervention was implemented as designed.
Measured: Surveys administered at the start of or just prior to period 1, during period 2, and during period 3. Interviews conducted during period 2 and period 3.
Secondary outcomes (7)
Rate of broad-spectrum (off-guideline) antibiotic prescribing by practice setting
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed by practice setting (Emergency department, urgent care, pediatric primary care, family medicine/medicine-pediatrics). Assessed using electronic health record data.
Measured: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of broad-spectrum (off-guideline) antibiotic prescribing by ARTI type
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed by ARTI type. Assessed using electronic health record data.
Measured: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of broad-spectrum (off-guideline) antibiotic prescribing by intervention participation status
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed by whether clinicians attested to completing study activities. Assessed using electronic health record data.
Measured: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of broad-spectrum (off-guideline) antibiotic prescribing by geographic location within each practice setting
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed by geographic location within each practice setting (Emergency department, urgent care, pediatric primary care, family medicine/medicine-pediatrics). Assessed using electronic health record data.
Measured: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by practice setting
The proportion of visits for all ARTIs (viral and bacterial) during which an antibiotic was prescribed by practice setting (Emergency department, urgent care, pediatric primary care, family medicine/medicine-pediatrics). Assessed using electronic health record data.
Measured: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by intervention participation status
The proportion of visits for all ARTIs (viral and bacterial) during which an antibiotic was prescribed by whether clinicians attested to completing study activities. Assessed using electronic health record data.
Measured: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by geographic location within each practice setting
The proportion of visits for all ARTIs (viral and bacterial) during which an antibiotic was prescribed by geographic location within each practice setting (Emergency department, urgent care, pediatric primary care, family medicine/medicine-pediatrics). Assessed using electronic health record data.
Measured: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start31 Oct 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics, University of Pennsylvania, MetroHealth System, Ohio, Penn State Health, Nationwide Children's Hospital, Pediatric Associates of Florida, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Jeffrey Gerber, MD PhD MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127161
- Sponsor's protocol ID
- 21-018912
- Acronym
- BIOS
- Status last verified
- Feb 2026
- First submitted
- 12 Nov 2021
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Broad Implementation of Outpatient Stewardship (BIOS) Project
- ClinicalTrials.gov ID
- NCT05127161
- Acronym / sponsor ID
- BIOS / 21-018912
- Keywords
- Pediatrics, Outpatient antibiotic stewardship, Broad-spectrum antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,032 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics, University of Pennsylvania, MetroHealth System, Ohio, Penn State Health, Nationwide Children's Hospital, Pediatric Associates of Florida, Patient-Centered Outcomes Research Institute
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Antibiotics are commonly prescribed for acute respiratory tract infections (ARTIs) in pediatric outpatient settings, but up to half of antibiotic use is inappropriate. Prior work demonstrated broad-spectrum antibiotics did not improve patient health outcomes compared to narrow-spectrum antibiotics, but did increase harmful side effects. Overuse of broad-spectrum antibiotics can exacerbate antibiotic resistance and drug-related adverse events. Certain interventions have been effective in improving antibiotic prescribing, but none have been implemented widely.
The BIOS project focuses on broadly implementing an evidence-based intervention to improve how clinicians in outpatient settings prescribe antibiotics for ARTIs in children 6 months to 12 years old. The intervention consists of educational modules and prescribing audit and feedback reports delivered to clinicians in a variety of outpatient settings across 5 health systems.
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.
Clinicians will be randomized to one of two arms: an early intervention arm or a delayed intervention (control) arm. The study will use a 4-period design, where the periods are as follows:
Period 0: Baseline period that occurs prior to randomization
Period 1: clinicians in the early intervention arm receive the intervention
Period 2: All clinicians (both arms) receive the intervention
Period 3: Maintenance period, external support from the study team is removed
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intervention | Experimental | Behavioral: Broad Implementation of Outpatient Stewardship (BIOS) interventionThe early intervention arm will begin receiving the intervention in study period 1. |
| Delayed Intervention (Control) | Other | Behavioral: Broad Implementation of Outpatient Stewardship (BIOS) interventionThe delayed intervention (control) arm will begin receiving the intervention in study period 2. They will receive no intervention during period 1. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
- Visit inclusion criteria: visits made by patients of all participating practices aged 6 months through 12 years of age will be considered part of the project population.
Key exclusion criteria (2 listed)
- 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
- Visit exclusion criteria: visit by children with complex chronic conditions, as well as those treated with an antibiotic in the past 30 days, will have their data extracted but will be excluded from analyses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broad Implementation of Outpatient Stewardship (BIOS) interventionThe BIOS intervention consists of 3 components: (1) online educational modules covering topics related to appropriate antibiotic prescribing for ARTIs, (2) individualized audit and feedback reports displaying clinicians' rates of antibiotic prescription with peer comparison, (3) facilitation provided by the study team and by health system champions to support effective implementation of the intervention and to encourage clinicians to engage meaningfully in the intervention activities. | Behavioural | Delayed Intervention (Control), Early Intervention |
Primary outcome
Rate of broad-spectrum (off-guideline) antibiotic prescribing for all bacterial ARTIs
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed. Assessed using electronic health record data.
Rate of antibiotic prescribing for all ARTIs (viral and bacterial)
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
The proportion of visits for all ARTIs (viral and bacterial) during which an antibiotic was prescribed
Engagement with intervention
Time frame: Period 1 through period 3 (up to 40 months of intervention time following intervention initiation)
Investigators will measure clinicians' completion rates of the educational modules and view rates of the feedback reports. Assessed through clinician attestation.
Implementation of the intervention
Time frame: Surveys administered at the start of or just prior to period 1, during period 2, and during period 3. Interviews conducted during period 2 and period 3.
Investigators will use surveys and qualitative interviews to measure the extent to which the intervention was implemented as designed.
7 secondary outcomes
Rate of broad-spectrum (off-guideline) antibiotic prescribing by practice setting
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of broad-spectrum (off-guideline) antibiotic prescribing by ARTI type
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of broad-spectrum (off-guideline) antibiotic prescribing by intervention participation status
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of broad-spectrum (off-guideline) antibiotic prescribing by geographic location within each practice setting
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by practice setting
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by intervention participation status
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by geographic location within each practice setting
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Gerber, MD PhD MSCE principal investigator
Children's Hospital of Philadelphia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broad Implementation of Outpatient Stewardship (BIOS) intervention in people with Acute Respiratory Tract Infection and Otitis Media, run by Children's Hospital of Philadelphia at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of broad-spectrum (off-guideline) antibiotic prescribing for all bacterial ARTIs (time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026; AzTrials last refreshed its copy on 2 Nov 2026.