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NOT YET RECRUITING
NCT07099976
NA

PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms

Sponsor: Jeffrey Pernica

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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).

OTHER

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