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Community Acquired Pneumonia (CAP)RAISINNCT07217002

Reducing Antibiotic Use by Implementation of Stewardship in Primary and Urgent Care

An observational study of Community Acquired Pneumonia (CAP) and Sinusitis, run by Children's Hospital of Philadelphia at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The goal of this project is to reduce unnecessary antibiotic use for children with ARTIs (Acute Respiratory Tract Infections) by implementing "outpatient antibiotic stewardship" across the Children's Hospital of Philadelphia (CHOP) Primary and Urgent Care Network to: 1. Read more about this study

Who is it for?
Ages 6 months to 12 years
What is being tested?
Online Educational Modules, Prescribing Feedback Reports and Clinical Decision Support
How many people
420 participants
Where
1 siteUnited States
Study dates
18 Feb 2025to May 2029
Phase
Observational

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
  • No healthy volunteers
  • Child

Study population: In two years, the project team will reach all 121,000 children 6 months to 12 years of age seen at 288,000 encounters for ARTIs at the Primary Care Practices and Urgent Care locations across the CHOP primary care and urgent care network.

Who may be able to join

  • All children ages 6 months to 12 years seen at CHOP primary care network and CHOP Urgent Care with ARTI diagnoses (viral diagnoses or AOM, CAP, sinusitis, strep pharyngitis) Exclusion
  • Severe immunocompromised status OR tracheostomy dependence
  • Children with other bacterial infection diagnoses

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

The goal of this project is to reduce unnecessary antibiotic use for children with ARTIs (Acute Respiratory Tract Infections) by implementing "outpatient antibiotic stewardship" across the Children's Hospital of Philadelphia (CHOP) Primary and Urgent Care Network to:

  1. Reduce unnecessary antibiotic prescribing for the most common infections in children.
  2. Reduce unnecessary a) broad-spectrum and b) longer-course antibiotic therapy for ear infections, Strep throat, sinus infections, and pneumonia.
Read the detailed description

Children often receive antibiotics for acute respiratory tract infections (ARTIs) which are caused by viruses, such as the common cold. However, antibiotics cannot treat viruses. Using antibiotics when they are not needed can cause harm - including side effects like rashes, vomiting and diarrhea - and can make it harder for the antibiotics to work when they are needed to treat infections caused by bacteria. For ARTIs caused by bacteria - like ear infections, sinus infections, strep throat or pneumonia - narrow-spectrum antibiotics are the best choice. This is because narrow-spectrum antibiotics target only the harmful bacteria, while "broad-spectrum" antibiotics target additional bacteria than can be helpful for the body. For many of these infections, it is also better to use shorter courses of antibiotics (such as five days) instead of longer courses (such as 10 days). Research studies have shown clearly that shorter courses and narrow-spectrum antibiotics cure infections just as well as longer courses and broad-spectrum antibiotics, but with fewer side effects.

Over two years, the project team will use proven strategies to ensure that children get the right antibiotics for the right amount of time. During this time, all pediatric doctors and nurse practitioners in this large, diverse network will receive:

  1. Online education about proper antibiotic prescribing.
  2. Regular feedback on how their antibiotic prescribing and group A strep testing compares to their peers and to professional guidelines.
  3. Tools in the electronic health record to make it easy to prescribe the right antibiotics.
  4. Yearly, live hybrid in-person and online educational sessions

The project team will determine how well this program works by measuring:

  1. How often antibiotics are prescribed to children with ARTIs.
  2. How often children with bacterial ARTIs (ear infections, sinus infections, strep throat and pneumonia) get the right antibiotic choice and right number of antibiotic days.
Being tested
Online Educational Modules, Prescribing Feedback Reports, Clinical Decision Support, Live, hybrid in-person and online educational sessions
Keywords
Antibiotics, Antimicrobial Stewardship
Medical subject headings
Community-Acquired Pneumonia, Sinusitis, Otitis Media

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Educational ModulesOther

    Online educational modules for clinicians that describe optimal antibiotic use and provide strategies to communicate with families about antibiotic prescribing for ARTIs. Modules are assigned through CHOP's internal learning website and assigned to every single primary care provider.

  • Prescribing Feedback ReportsOther

    Prescribing feedback reports distributed quarterly that show clinicians how their prescribing and Group A Strep testing compares to their peers and to professional guideline recommendations. Will include metrics of overall prescribing and show choice and duration for antibiotics given ear infections, Strep throat, sinus infections, and pneumonia. The goal of the feedback reports is to show clinicians how often they are prescribing antibiotics, and when they do prescribe antibiotics are they doing so with right antibiotic and for the correct duration.

  • Clinical Decision SupportOther

    Clinical decision support built into the electronic health record to help clinicians choose the right antibiotics for the right number of days. Using information from guidelines and clinical pathways created by CHOP to help providers continue to optimize their prescribing practices.

  • Live, hybrid in-person and online educational sessionsOther

    Live, hybrid in-person and online educational sessions that explain the project, describe best prescribing practices and allow clinicians to talk directly with project team members. Study leaders visit all 31 practices across the network.

Study groups in NCT07217002
Study groupRoleWhat they receive
CHOP Primary Care ProvidersProviders at all 30 primary care practice offices and 4 urgent care offices that include physicians and Advanced Practice Provider (APPs) including Nurse Practitioners (NPs) and Physicians Assistants (PAs).
Receives: Other: Online Educational Modules; Other: Prescribing Feedback Reports; Other: Clinical Decision Support; Other: Live, hybrid in-person and online educational sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antibiotic Prescribing Rates for Acute Respiratory Tract Infections (ARTIs)

    ARTIs as measured by overall rates of prescribing an antibiotic during clinic visits for an acute respiratory tract infection (URI) diagnosis, including both bacterial and viral URIs using the EHR (electronic health record). Goal is that antibiotics are prescribed at 40% or fewer ARTI visits. The optimal proportion of ARTI visits that should be associated with an antibiotic prescription is unknown. Baseline prescribing rates for antibiotics in the Network ranges from 34-61%. The target 40% rate is currently achieved by 10% of our practices with the lowest antibiotic prescribing.

    Measured: From start of implementation ramp up period to end of year 2 implementation

  2. Change in overall optimal antibiotic prescribing rates for all bacterial ARTI encounters

    Changing overall antibiotic prescribing rates as measured by a composite of 1) narrow antibiotic selection and 2) shortest effective duration as a proportion of all antibiotics prescribed for each of the target diagnoses: Acute otitis media, Group A streptococcal pharyngitis, Acute sinusitis, and Pneumonia using EHR (electronic health record) data. This metric combines both narrow-spectrum antibiotic choice and optimal durations of therapy to comprehensively evaluate optimal antibiotic prescribing. At least 90% of antibiotics prescribed for ARTI are for optimal short duration and narrow spectrum antibiotics

    Measured: From start of implementation ramp up period to end of year 2 implementation

  3. Broad- versus Narrow-Spectrum Antibiotic Prescribing

    Broad vs. Narrow-Spectrum antibiotic prescribing as measured by rates of broad-spectrum antibiotics as a proportion of all antibiotics prescribed within each of these diagnoses using the EHR (electronic health record):

    • acute otitis media
    • Group A streptococcal pharyngitis
    • acute sinusitis
    • pneumonia At least 90% of antibiotics prescribed for ARTI are for optimal narrow spectrum antibiotics.

    Measured: From start of implementation ramp up period to end of year 2 implementation

  4. Shortest Effective Duration Antibiotic Prescribing

    Shortest effective duration measured by rates of prescribing the shortest effective duration of antibiotics as a proportion of all antibiotics prescribed within each of these diagnoses:

    • acute otitis media
    • Group A streptococcal pharyngitis
    • acute sinusitis
    • pneumonia At least 90% of antibiotics prescribed for ARTI are for the shortest effective duration of antibiotics. Optimizing durations of therapy will reduce overall antibiotic days and, therefore, decrease the overall antibiotic burden for children with ARTIs.

    Measured: From start of implementation ramp up period to end of year 2 implementation

Secondary outcomes (3)
  1. Treatment failure or modification 14 days

    Treatment failure measured at 14 days if there is in person or telephone contact with the same ARTI diagnosis with receipt of any systemic ARTI-directed antibiotic found in the EHR. The target is for no increase in treatment failure.

    Measured: 14 days

  2. Antibiotic-associated adverse events (AEs) within 7 days of completing antibiotics

    AEs as measured by in person or telephone contact for diarrhea, candidiasis, non-candidal rash, other or unspecified allergic reaction, other or unspecified adverse event, and vomiting using the EHR.

    Measured: From index visit to 7 days of completing antibiotics

  3. Group A Strep Testing

    Proportion of ARTI visits with a Group A Strep Test.

    Measured: From start of implementation ramp up period to end of year 2 implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2025
  2. Study start18 Feb 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07217002
Sponsor's protocol ID
24-021996
Acronym
RAISIN
Status last verified
Apr 2026
First submitted
9 Oct 2025
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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