Novel Care Pathway for Pneumonia

(PIONEERS Trial)

Not yet recruiting at 5 trial locations

Overseen By Jeffrey Pernica, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Jeffrey

Must not be taking: Amoxicillin, Cefprozil, others

Disqualifiers: Cystic fibrosis, Anatomic lung disease, others

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

Compensation: Varies

Number of Visits: 5

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the management of community-acquired pneumonia (CAP) in children by testing a new care pathway. The study will assess risk factors to determine the necessity of antibiotics, helping to reduce unnecessary medication use. Researchers will divide participants into two groups: one receiving the novel care pathway intervention and the other receiving standard care. Children with a recent fever, cough, or breathing issues diagnosed with non-severe CAP may be eligible. This research seeks to ensure children receive the right treatment while minimizing hospital stays and complications. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance pediatric care practices.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if your child has been on certain antibiotics like amoxicillin or levofloxacin for more than 4 days without improvement, they won't be eligible to join.

What prior data suggests that this novel care pathway is safe for managing pneumonia in preschoolers?

Research has shown that a new method for treating pneumonia in children aims to reduce unnecessary antibiotic use. This approach employs in-office tests to identify which children truly need antibiotics for bacterial pneumonia. Studies suggest this could lead to fewer antibiotic prescriptions. However, some children might experience a return of pneumonia symptoms if they don't receive antibiotics when necessary.

No major safety issues have been reported with this approach so far. It primarily relies on existing tests and guidelines to determine treatment, which has proven generally safe. Prospective participants should consult healthcare providers to understand the potential benefits and risks before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the novel care pathway for pneumonia because it personalizes treatment based on a patient's risk level. Unlike the standard approach, which typically involves prescribing antibiotics like amoxicillin to many patients, this method uses point-of-care CRP testing and bioMérieux Spotfire testing to determine if a patient is at high risk of bacterial community-acquired pneumonia. This allows for targeted antibiotic use only when necessary, potentially reducing unnecessary antibiotic exposure and fighting antibiotic resistance. By tailoring treatment to individual risk, this pathway could improve patient outcomes and streamline care in emergency departments.

What evidence suggests that this novel care pathway intervention is effective for managing pneumonia in preschoolers?

Research has shown that a new care plan, available to participants in this trial, might reduce unnecessary antibiotic prescriptions for children with community-acquired pneumonia (CAP). This plan employs quick tests to assess the risk of bacterial infection, aiding doctors in determining the need for antibiotics. Studies indicate that similar strategies enhance antibiotic use, making treatment more effective. By targeting children at higher risk, this approach seeks to reduce antibiotic overuse, which is crucial for preventing resistance. Overall, the new care plan aims to improve treatment by administering antibiotics only to those who truly need them. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for preschoolers in North America who have developed community-acquired pneumonia (CAP). The study aims to include children who need hospitalization due to CAP, but specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

My child, aged 6 months to 18 years, has pneumonia but can go home from the ER.

I have a fever and symptoms like fast breathing, cough, or difficulty breathing.

Exclusion Criteria

Children with: Cystic Fibrosis, Anatomic Lung Disease, Bronchiectasis, Chronic Lung Disease requiring home oxygen or home ventilation, Congenital heart Disease requiring specific medical treatment or with exercise restrictions, History of repeated aspiration/velopharyngeal incompetence, Malignancy, Immunodeficiency (primary, acquired or iatrogenic), Pneumonia clinically diagnosed within the past month presumed to have resolved prior to the current visit to the ED, Lung abscess within the past 6 months, Ongoing fever after 4 days of specific antibiotics, Participation in the study more than once

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive the novel care pathway intervention or standard care, with antibiotic prescription based on risk assessment

7 days

1 visit (in-person) on day 0

Follow-up

Participants are monitored for clinical response and antibiotic use, with assessments at day 4, day 15, and day 30

30 days

3 visits (in-person or virtual) on days 4, 15, and 30

What Are the Treatments Tested in This Trial?

Interventions

• Novel Care Pathway Intervention

Trial Overview The trial is testing a new care pathway for treating CAP against the usual care alone. It's designed to see if this novel approach can improve outcomes for young children hospitalized with pneumonia.

How Is the Trial Designed?

Group I: The novel care pathway intervention Experimental Treatment 1 Intervention

The novel care pathway intervention will incorporate multiple factors to determine risk of bacterial CAP. At recruitment, POC CRP testing, and bioMérieux Spotfire testing of nasopharyngeal swabs (NPS) will identify those who are at appreciable risk and will receive a prescription for antibiotic treatment on day 0. Please refer to the Specimen Collection and Processing manual for more specific information on the collection process. Appreciable-risk participants will be referred back to the clinical team to be given amoxicillin, the current standard of care in Canada (those with penicillin allergy will presumably receive an appropriate substitution as per local guidelines). Low-risk participants will be discharged home without antibiotics.

Group II: Control Group Active Control 1 Intervention

Participants will be recruited in the ED and will be managed as per the treating clinician; the study team will not influence management

Who Is Running the Clinical Trial?

Jeffrey

Lead Sponsor

Trials

2

Recruited

150+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9677018/

Novel care pathway to optimise antimicrobial prescribing ... The novel care pathway will likely result in fewer antibiotic prescriptions, and so could potentially be associated with recrudescence of CAP and symptoms ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07099976

Study Details | NCT07099976 | PromotIng Optimal ... The novel care pathway intervention will incorporate multiple factors to determine risk of bacterial CAP. At recruitment, POC CRP testing ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/12/11/e062360.abstract

Novel care pathway to optimise antimicrobial prescribing ... The primary outcome will be the proportion of participants in each phase who receive antimicrobial treatment for CAP.

4. academic.oup.com academic.oup.com/ofid/article/7/11/ofaa497/5930832

A Pathway for Community-Acquired Pneumonia With Rapid ... A CDS-driven CAP pathway supplemented by active antimicrobial stewardship review led to the most robust improvements in antibiotic use and ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/14787210.2023.2257392

Interventions to improve outcomes in community-acquired ... In this review, we aim to provide a critical account of potential measures to improve outcomes of CAP and the supporting evidence from observational studies ...

6. withpower.com withpower.com/trial/phase-community-acquired-pneumonia-cap-8-2025-faa32

Novel Care Pathway for Pneumonia · Info for Participants The novel care pathway intervention will incorporate multiple factors to determine risk of bacterial CAP. At recruitment, POC CRP testing, and bioMérieux ...