← Back to Search

Care Pathway Optimization for Pneumonia (PIONEER Trial)

N/A
Recruiting
Led By Jeffrey Pernica, MD
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have tachypnoea, cough, increased work of breathing, or auscultatory findings consistent with pneumonia.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of enrolment, day 2-5, day 14-21 and day 30 follow-up
Awards & highlights

PIONEER Trial Summary

This trial is testing a way to better care for children with pneumonia by only giving antibiotics to those who will benefit, so that we can decrease antibiotic prescription while maintaining equal clinical outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the intervention involves reducing antibiotic use when not necessary rather than testing a new drug, side effects would mainly relate to monitoring any progression of illness due to withholding antibiotics in cases where they might have been prescribed under usual care.

PIONEER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You must have symptoms like fast breathing, cough, or difficulty breathing that are consistent with pneumonia.

PIONEER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of enrolment, day 2-5, day 14-21 and day 30 follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of enrolment, day 2-5, day 14-21 and day 30 follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment with antibiotics for community-acquired pneumonia
Secondary outcome measures
Caregiver satisfaction with the care plan
Clinical cure
Pleural effusion disorder
+11 more

PIONEER Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Novel Care PathwayExperimental Treatment1 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 careActive Control1 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.

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
366 Previous Clinical Trials
300,751 Total Patients Enrolled
1 Trials studying Community-acquired Pneumonia
281 Patients Enrolled for Community-acquired Pneumonia
Jeffrey Pernica, MDPrincipal InvestigatorHamilton Health Sciences Corporation
3 Previous Clinical Trials
352 Total Patients Enrolled

Media Library

Novel Care Pathway Clinical Trial Eligibility Overview. Trial Name: NCT05114161 — N/A
Community-acquired Pneumonia Research Study Groups: Novel Care Pathway, Standard care
Community-acquired Pneumonia Clinical Trial 2023: Novel Care Pathway Highlights & Side Effects. Trial Name: NCT05114161 — N/A
Novel Care Pathway 2023 Treatment Timeline for Medical Study. Trial Name: NCT05114161 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current population involved with this clinical trial?

"Affirmative, the information hosted on clinicaltrials.gov denotes that this medical trial is now recruiting patients. This experiment was first made available February 14th 2022 and most recently modified September 17th 2022; 154 individuals are required to be enrolled from one site."

Answered by AI

Who would be ideal participants for this medical research?

"To be accepted, applicants must have infants or children between the ages of 6 Months and 18. Recruitment efforts are currently underway for 154 trial subjects."

Answered by AI

Are there any openings left to take part in this investigation?

"Affirmative. According to the clinicaltrials.gov registry, this research is actively soliciting participants and has been since February 14th 2022 (with a recent update on September 17th). This study seeks 154 individuals from 1 medical centre."

Answered by AI

Does this clinical research accept participants who are 18 years of age or older?

"This research paper specifies that applicants aged between 6 months and 18 years old are qualified to participate. 65 trials focus on youth under the age of 18, whereas 303 clinical studies target individuals above the seniority of 65."

Answered by AI
~6 spots leftby May 2024