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Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER)

NCT05114161 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2024-04-19

No results posted yet for this study

Summary

Pneumonia in children can be caused by different types of germs such as bacteria and viruses. Giving antibiotics to children with bacterial bugs is helpful while giving antibiotics to children with viruses will not help them. Unfortunately, it is difficult for doctors to tell when a child's pneumonia is caused by bacteria or viruses. Most young children are given antibiotics even though it doesn't help them.

Our study wants to test a new way to care for children with pneumonia so that only children who will benefit from antibiotics will receive them. The study will use a combination of the child's symptoms, x-rays results, and lab testing to better determine if a child needs antibiotics. The study team will then review the testing results and follow up with the patient and their family in the following days to ensure that the child is improving. PIONEER will test a novel care pathway for treating non-severe pediatric pneumonia with the goal of decreasing antibiotic prescription while maintaining equal clinical outcomes to standard care.

Conditions

  • Community-acquired Pneumonia

Interventions

OTHER

Novel Care Pathway

The novel care pathway will follow a decision tree based on several criteria to stratify patients in an appropriate risk category. Patients with large radiographic lobar consolidation OR POC CRP \> 60mg/L will be deemed 'appreciable risk' while patients with CRP \< 20mg/L will be deemed 'low risk'. Patients with CRP between 20 - 60mg/L will be evaluated further, as follows: if they have an oxygen saturation of \<95%, they will be 'appreciable risk', and if not, there are further decision points: if they are not tachypneic, they will be 'low risk'; if they are tachypneic and less than 1 year of age, they will be 'appreciable risk'; if they are tachypneic, over 1 year of age, but with either complete PCV13 immunization OR detectable wheezing as per the ED clinician, they will be classified as 'low risk'. Appreciable-risk participants will be given a prescription for antibiotics at ED discharge.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Jeffrey Pernica, MD · Hamilton Health Sciences Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2024-03-30
Completion
2024-04-18

Countries

  • Canada

Study Locations

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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 NCT05114161 on ClinicalTrials.gov