Care Pathway Optimization for Pneumonia

(PIONEER Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jeffrey Pernica, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Hamilton Health Sciences Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?

Pneumonia in children can be caused by different types of germs such as bacteria and viruses. Giving antibiotics to children with bacterial bugs is helpful while giving antibiotics to children with viruses will not help them. Unfortunately, it is difficult for doctors to tell when a child's pneumonia is caused by bacteria or viruses. Most young children are given antibiotics even though it doesn't help them. Our study wants to test a new way to care for children with pneumonia so that only children who will benefit from antibiotics will receive them. The study will use a combination of the child's symptoms, x-rays results, and lab testing to better determine if a child needs antibiotics. The study team will then review the testing results and follow up with the patient and their family in the following days to ensure that the child is improving. PIONEER will test a novel care pathway for treating non-severe pediatric pneumonia with the goal of decreasing antibiotic prescription while maintaining equal clinical outcomes to standard care.

Research Team

Jeffrey Pernica, MD

Principal Investigator

Hamilton Health Sciences Corporation

Eligibility Criteria

The PIONEER trial is for children diagnosed with community-acquired pneumonia who can be treated at home. They must show symptoms like rapid breathing, coughing, or signs of pneumonia on a physical exam. Kids with cystic fibrosis, heart disease, immune problems, recent pneumonia or lung abscesses, or those already on antibiotics for 4 days aren't eligible.

Inclusion Criteria

Diagnosed primarily with community-acquired pneumonia as per the ED MD and are well enough to be discharged home.

You must have symptoms like fast breathing, cough, or difficulty breathing that are consistent with pneumonia.

Exclusion Criteria

Children with ongoing fever after 4 or more days of specific antibiotic therapy will not be eligible.

Children will not be eligible to participate more than once.

Children with certain medical conditions affecting the lungs or immune system will not be included in the study.

Treatment Details

Interventions

• Novel Care Pathway (Behavioural Intervention)

Trial Overview This study tests a new care pathway to treat non-severe pediatric pneumonia by using symptoms assessment, x-rays and lab tests to decide if antibiotics are needed. The goal is to reduce unnecessary antibiotic use while ensuring kids recover as well as they do with standard treatment.

Participant Groups

Group I: Novel Care Pathway Experimental Treatment 1 Intervention

Once a child is diagnosed with non-severe CAP (community-acquired pneumonia) in the ED, specific radiographic findings and point-of-care CRP testing will identify those who require antibiotic treatment immediately. The next day, results of multiplex respiratory pathogen and urine pneumococcal antigen (UAg, optional) testing will be integrated into the care plan, along with additional clinical information about the child gathered remotely, to ensure that only children at appreciable risk for bacterial infection receive antibiotics. Our care pathway uses already-available testing (NPS) in new ways, integrates newer diagnostics (point-of-care CRP, UAg), and includes properly-timed clinical follow up to change how children with non-severe CAP are managed.The research team will follow-up with the participant and caregiver the next day, 2-5 days, 7-21 days and day 30 post-enrolment to ensure clinical stability.

Group II: Standard care Active Control 1 Intervention

All participants/caregivers will be asked for consent for point-of-care (POC) blood C-reactive protein (CRP), nasopharyngeal swab for virology/Mycoplasma testing, and urine for pneumococcal antigen (UAg) testing, but, since this testing will not affect care, these are optional (ie. refusal will not preclude enrolment). The RA will phone the caregiver at Day 2-5, Day 14-21, and Day 30 post-enrollment, for outcome ascertainment. Caregivers will be asked to fill out a daily diary (either electronically or on paper) to record the participant's symptoms, clinical progress, and possible drug adverse effects. Caregivers will also be instructed on how to take patient temperature. All participants whose symptoms do not progressively improve will be encouraged to return to the ED to be reassessed, as per standard of care.

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

Dr. Craig A. VanHelder

Hamilton Health Sciences Corporation

Chief Medical Officer since 2023

MD

Tracey MacArthur

Hamilton Health Sciences Corporation

Chief Executive Officer

MSc in Quality Improvement & Patient Safety from the University of Toronto, Honours BA in Psychology from the University of Waterloo, Masters Certificate in Project Management from the Schulich School of Business at York University