Improving treatment for children with 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
This project tests a new care pathway to see if emergency departments can safely give fewer antibiotics to children aged 6 months–18 years with non-severe community-acquired pneumonia who are sent home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 698 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 6 sites (Calgary, Alberta and 5 other locations) |
| Trial ID | NCT07099976 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares a novel care pathway against usual care for children diagnosed with non-severe community-acquired pneumonia in participating pediatric emergency departments. Eligible children are 6 months to 18 years old, have fever and respiratory signs consistent with pneumonia, and are well enough to be discharged; children with chronic lung disease, cystic fibrosis, immunodeficiency, malignancy, or other major comorbidities are excluded. The pathway is designed to help clinicians better target antibiotic use given the high frequency of viral and mixed infections in pediatric CAP. The trial is being conducted at three Canadian pediatric centers in Calgary, Edmonton, and Vancouver to measure whether the pathway reduces unnecessary antibiotic prescribing while maintaining safe clinical outcomes.
Who should consider this trial
Good fit: Children aged 6 months to 18 years presenting to participating emergency departments with non-severe community-acquired pneumonia who are well enough to be discharged and meet the fever plus respiratory sign criteria.
Not a fit: Children with severe illness requiring admission or with exclusions such as cystic fibrosis, bronchiectasis, chronic lung disease on home oxygen/ventilation, significant congenital heart disease, malignancy, or immunodeficiency are not eligible and would not benefit from this outpatient-focused pathway.
Why it matters
Potential benefit: If successful, the pathway could reduce unnecessary antibiotic use in children, lowering side effects and slowing the spread of antimicrobial resistance.
How similar studies have performed: Antibiotic stewardship and clinical-pathway programs have reduced antibiotic use in some settings, but reliably distinguishing viral from bacterial pediatric CAP remains difficult and this specific care-pathway approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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
Where this trial is running
Calgary, Alberta and 5 other locations
- Alberta Children's hospital — Calgary, Alberta, Canada (Recruiting)
- Stollery Children's Hospital — Edmonton, Alberta, Canada (Not_yet_recruiting)
- BC Children's Hospital — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- McMaster Children's Hospital — Hamilton, Ontario, Canada (Not_yet_recruiting)
- Children's Hospital of Eastern Ontario (CHEO) — Ottawa, Ontario, Canada (Recruiting)
- The Hospital for Sick Children — Toronto, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Jeffrey Pernica, MD
- Email: pernica@mcmaster.ca
- Phone: 905-521-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.