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

Inclusion Criteria5

Children aged 6 month to 18 years presenting to the Emergency Department who are diagnosed with CAP and are well enough to be discharged home (i.e. 'non-severe' CAP) will be eligible. They must have a fever (on exam or by history) and at least one of:
Tachypnoea measured at triage (>60 bpm for age <1, >50 for 1-2 years of age, >40bpm for 2-4 years of age, and >30bpm for >4 years of age)
Cough on exam or by history
Increased work of breathing on exam
Auscultatory finding (focal crackles, bronchial breathing, etc.) consistent with CAP

Exclusion Criteria13

Children will be excluded if they have any of the following
Cystic Fibrosis
Anatomic Lung Disease
Bronchiectasis
Chronic Lung Disease requiring home oxygen or home ventilation
Congenital heart Disease (requiring specific medical treatment or with exercise restrictions),
History of repeated aspiration/velopharyngeal incompetence
Malignancy
Immunodeficiency (primary, acquired or iatrogenic)
Pneumonia previously (clinically) diagnosed within the past month (that was presumed to have resolved prior to the episode prompting the current visit to the ED)
Lung abscess within the past 6 months
Children who present with ongoing fever after 4 days of amoxicillin, cefprozil, cefuroxime, levofloxacin, moxifloxacin or doxycycline are not eligible; as this duration of therapy with these drugs would normally be sufficient to treat bacterial CAP, a different approach would be required (ie. the care pathway as written might not be appropriate).
Children will not be eligible to participate more than once

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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.