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PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms

ConditionsCommunity-Acquired Pneumonia (CAP)Pneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorJeffrey Pernica

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Cystic Fibrosis

Anatomic Lung Disease

Bronchiectasis

Chronic Lung Disease requiring home oxygen or home ventilation

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Participants will be recruited in the ED and will be managed as per the treating clinician; the study team will not influence management.

Treatment groups

698 Participants
are divided into 2 treatment groups
Group A: The novel care pathway interventionExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Antibiotic use for CAP or respiratory tract infection before day 7 post-enrolment

The proportion of patients who receive antibiotics.

Time frame
From enrollment to 7 days post enrollment
2

Early clinical response (ECR, clinical improvement in symptoms and lack of requirement for additional antibacterials as measured at day 4).

At baseline/enrollment, caregivers will be asked to rank all of the child's symptoms (work of breathing, dyspnoea \[for children over the age of 7\], oral intake, and activity level) as compared to normal. These will be categorized as the following: "same as normal", "a little worse than normal", and "a lot worse than normal". At the day 4, and day 15 follow-ups, caregivers will be asked to rank the child's symptoms as compared to the previous visit. These will be categorized as the following: "worse", "about the same", "a little better", "a lot better". Clinical response requires at least "a little better" for any symptom that was not "same as normal" at baseline. Dyspnoea will be self-reported in children over the age of seven. For those under seven, dyspnoea will not be reported.

Time frame
From enrollment to day 4

Secondary outcomes

1

Ordinal outcome variable

This variable will include early clinical response, drug adverse events, and hospitalization to generate an ordinal outcome variable with ranks 1-8. Ranks 1-3 have ECR being met with no AEs; mild-moderate AEs; and severe AEs, respectively. Ranks 4-6 are associated with NOT achieving ECR with no AEs; mild-moderate AEs; and severe AEs, respectively. Rank 7 is no ECR plus hospitalization with no AEs, and rank 8 is no ECR with hospitalization and any AE.

Time frame
From enrollment to end of 30 day follow up
2

Time to resolution of both fever and iincreases work of breathing

Time frame
From enrollment to end of 30 day follow up
3

Late clinical response

Defined same as early clinical response but measured at day 15 as compared to day 4

Time frame
From enrollment to day 15
4

Proportion of participants with antibiotic use specifically for CAP or respiratory tract infection before day 30

Time frame
From enrollment to end of 30 day follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jeffrey Pernica

Lead sponsor

McMaster University

Sponsor institution

Source ClinicalTrials.gov
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