PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms

Sponsor
Jeffrey Pernica
Study ID
NCT07099976
Status
Recruiting
Apply to this trial

Conditions

  • Community-Acquired Pneumonia (CAP)
  • Pneumonia

Eligibility Criteria

Sex
ALL
Age
6 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • The novel care pathway intervention — DIAGNOSTIC_TEST
    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 — OTHER
    Participants will be recruited in the ED and will be managed as per the treating clinician; the study team will not influence management.

Study Details

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.

Key Dates

First listed
Aug 1, 2025
Start date
Apr 15, 2026
Status verified
Apr 2026
Primary completion
Apr 15, 2030
Completion
May 15, 2030

Study Design

Enrollment
698 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: The novel care pathway intervention
    The novel care pathway intervention will incorporate multiple factors to determine risk of bacterial CAP. At recruitment, POC CRP testing, and bioMérieux Spotfire testing of nasopharyngeal swabs (NPS) will identify those who are at appreciable risk and will receive a prescription for antibiotic treatment on day 0. Please refer to the Specimen Collection and Processing manual for more specific information on the collection process. Appreciable-risk participants will be referred back to the clinical team to be given amoxicillin, the current standard of care in Canada (those with penicillin allergy will presumably receive an appropriate substitution as per local guidelines). Low-risk participants will be discharged home without antibiotics.
  • Active Comparator: Control Group
    Participants will be recruited in the ED and will be managed as per the treating clinician; the study team will not influence management

Primary Outcome Measure

Antibiotic use for CAP or respiratory tract infection before day 7 post-enrolment [ Time Frame: From enrollment to 7 days post enrollment ]

Central Contacts

Related Studies