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PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms

NCT07099976 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 698

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Community-Acquired Pneumonia (CAP)
  • Pneumonia

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.

Sponsors & Collaborators

  • Jeffrey Pernica

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2030-04-15
Completion
2030-05-15

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07099976 on ClinicalTrials.gov