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PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms
Sponsor: Jeffrey Pernica
Summary
In North America, up to 5% of preschoolers develop community-acquired pneumonia (CAP) every year. Pneumonia is the second-leading reason for paediatric hospitalization in both Canada and the US; approximately 20% of children hospitalized with CAP may need intensive care, which can result in significant morbidity. Given this burden of disease, it is critical that CAP is managed appropriately. Specific therapy for CAP is dependent on microbiologic aetiology, as bacterial disease will improve with antibiotic treatment.
Official title: PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms (PIONEERS): a Multicentre, Randomized, Open-labelled, Controlled, Clinical Trial
Key Details
Gender
All
Age Range
6 Months - 18 Years
Study Type
INTERVENTIONAL
Enrollment
698
Start Date
2026-03-15
Completion Date
2030-12-30
Last Updated
2026-02-20
Healthy Volunteers
No
Interventions
The novel care pathway intervention
The pathway uses already-ascertained data, bioMérieux Spotfire testing, and POC CRP testing to stratify patients into risk categories. The first step in the pathway will be POC CRP testing; children with CRP \> 60 mg/L will be deemed 'appreciable risk', whereas those with CRP \< 20 mg/L will be deemed 'low risk'. The CRP cut-offs of 20mg/L (more sensitive) and 60mg/L (more specific) were selected after reviewing the literature, with particular emphasis on meta-analyses; other large recent studies have also used 60mg/L as an upper cut-off for bacterial infection. Participants with CRP between 20-60mg/L will be categorized further to identify children either more likely to have bacterial pneumonia or more intolerant of misclassification. 'If they have O2 saturation \<95% AND tachypnoea as per age-specific norms, they will be 'appreciable risk' (\>60 bpm for age \<1 y, \>50 bpm for 1-2 y, \>40 bpm for 2-4 y, and \>30 bpm for \>4 y).
Usual Care Alone
Participants will be recruited in the ED and will be managed as per the treating clinician; the study team will not influence management.
Locations (6)
Alberta Children's hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario (CHEO)
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada