Actively Recruiting
PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms (PIONEERS): a Multicentre, Randomized, Open-labelled, Controlled Clinical Trial
Led by Jeffrey Pernica · Updated on 2026-04-29
698
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying community-acquired pneumonia (CAP) in children aged 6 months to 18 years who visit emergency departments with non-severe CAP, aiming to improve antibiotic use. CAP is a common cause of hospitalization in young children, and distinguishing between viral and bacterial pneumonia is difficult. This study evaluates a new care pathway designed to better identify bacterial infections and reduce unnecessary antibiotic prescriptions, addressing the growing problem of antibiotic resistance. The study compares a novel care pathway intervention to usual care. The intervention uses point-of-care C-reactive protein (CRP) testing and bioM e9rieux Spotfire testing of nasopharyngeal swabs to assess bacterial risk. Children identified as appreciable risk receive antibiotics like amoxicillin, while low-risk children are sent home without antibiotics. Participants in the control group receive standard care without influence from the study team. Participants will be assessed through clinical evaluations, CRP tests, and nasopharyngeal swabs at enrollment. Researchers will track antibiotic use within 7 days and early clinical response by day 4, along with other outcomes such as symptom resolution, hospitalization, adverse events, and caregiver perspectives over 30 days. The study runs from enrollment through 30 days of follow-up to measure how well the care pathway guides antibiotic use and clinical outcomes.
CONDITIONS
Brief Title
PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 months to 18 years
- Diagnosed with community-acquired pneumonia (CAP)
- Well enough to be discharged home (non-severe CAP)
- Have a fever (measured or by history)
- Have at least one of the following: tachypnoea by age-specific rates, cough, increased work of breathing, or lung exam findings consistent with CAP
You will not qualify if you...
- Cystic fibrosis
- Anatomic lung disease
- Bronchiectasis
- Chronic lung disease requiring home oxygen or ventilation
- Congenital heart disease requiring treatment or exercise restrictions
- History of repeated aspiration or velopharyngeal incompetence
- Malignancy
- Immunodeficiency (primary, acquired, or iatrogenic)
- Pneumonia diagnosed within the past month related to current episode
- Lung abscess within the past 6 months
- Ongoing fever after 4 days of specified antibiotic treatments
- Prior participation in this study (only one participation allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day 0 (enrollment day)
Participants undergo point-of-care C-reactive protein (POC CRP) testing and bioMérieux Spotfire testing of nasopharyngeal swabs to stratify risk of bacterial pneumonia and guide antibiotic use.
1 baseline visit (in-person)
Duration - Up to 30 days post enrollment
Participants are monitored for clinical response, antibiotic use, and safety outcomes following their initial evaluation and treatment decision.
Follow-up visits or contacts as needed up to 30 days
Trial Site Locations
Total: 6 locations
1
Alberta Children's hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
2
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Not Yet Recruiting
3
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Not Yet Recruiting
4
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8S 4K1
Not Yet Recruiting
5
Children's Hospital of Eastern Ontario (CHEO)
Ottawa, Ontario, Canada, K1H 8M8
Actively Recruiting
6
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1E8
Not Yet Recruiting
Research Team
J
Jeffrey Pernica, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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