RecruitingNot ApplicableNCT07099976

PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms

PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms (PIONEERS): a Multicentre, Randomized, Open-labelled, Controlled, Clinical Trial

Sponsor

Jeffrey Pernica

Enrollment

698 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

Pneumonia Community-Acquired Pneumonia (CAP)

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.

Eligibility

Min Age: 6 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying The novel care pathway intervention and Usual Care Alone for people with community-acquired pneumonia (cap) and pneumonia. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 6 Months to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTThe 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).

OTHERUsual 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.