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.
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
- Conditions the study is for
- Community Acquired Pneumonia (CAP), Sinusitis, Strep Pharyngitis
- 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
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:
- Reduce unnecessary antibiotic prescribing for the most common infections in children.
- 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:
- Online education about proper antibiotic prescribing.
- Regular feedback on how their antibiotic prescribing and group A strep testing compares to their peers and to professional guidelines.
- Tools in the electronic health record to make it easy to prescribe the right antibiotics.
- Yearly, live hybrid in-person and online educational sessions
The project team will determine how well this program works by measuring:
- How often antibiotics are prescribed to children with ARTIs.
- 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.
- Conditions
- Community Acquired Pneumonia (CAP), Sinusitis, Strep Pharyngitis, Acute Otitis Media (AOM)
- 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 group | Role | What they receive |
|---|---|---|
| CHOP Primary Care Providers | Providers 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.
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
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
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
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)
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
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
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.
- First posted15 Oct 2025
- Study start18 Feb 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired Pneumonia (CAP)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Rebecca Same, MD, Principal investigator, Children's Hospital of PhiladelphiaLouis Bell, MD, Principal investigator, Children's Hospital of Philadelphia
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