PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms

NCT07099976 | Recruiting DMC

• 1 other identifier: 5063-CTIA-Mar/2025-118722
• Study Type: interventional
• Target: 698
• Locations: 1 country
• Sites: 6

Brief 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

Pneumonia; Community-Acquired Pneumonia (CAP)

Keywords

Pneumonia; Antibiotics

Outcome Measures

Primary Outcomes (2)

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

  The proportion of patients who receive antibiotics.

  From enrollment to 7 days post enrollment

• 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.

  From enrollment to day 4

Secondary Outcomes (12)

• Ordinal outcome variable

  From enrollment to end of 30 day follow up

• Time to resolution of both fever and iincreases work of breathing

  From enrollment to end of 30 day follow up

• Late clinical response

  From enrollment to day 15

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

  From enrollment to end of 30 day follow up

• Hospitalization for CAP before day 30

  From enrollment to end of 30 day follow up

Study Arms (2)

The novel care pathway intervention

EXPERIMENTAL

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.

Diagnostic Test: The novel care pathway intervention

Control Group

ACTIVE COMPARATOR

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

Other: Usual Care Alone

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).

The novel care pathway intervention

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.

Control Group

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeffrey Pernica: lead

Study Sites (6)

Alberta Children's hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

NOT YET RECRUITING

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

NOT YET RECRUITING

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

NOT YET RECRUITING

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Ontario, K1H 8M8, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1E8, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases

Central Study Contacts

Jeffrey Pernica, MD

CONTACT

905-521-2100; pernica@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: August 1, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2030
• Study Completion (Estimated): May 15, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)