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

Hamilton Health Sciences (HHS)

Status: Completed

Conditions: Community-acquired Pneumonia

Treatments: Other: Novel Care Pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT05114161

HAH-20-12

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed primarily with community-acquired pneumonia as per the ED MD and are well enough to be discharged home.

2. They also must have any one of:

   1. tachypnoea;
   2. cough;
   3. increased work of breathing; or
   4. auscultatory findings consistent with pneumonia;

Exclusion criteria

Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease (requiring treatment or with exercise restrictions), history of repeated aspiration/velopharyngeal incompetence, malignancy (current or past), immunodeficiency (primary, acquired, or iatrogenic), pneumonia previously (clinically) diagnosed within the past month, or lung abscess diagnosed within the past six months. Children who present with ongoing fever after 4 or more days of beta-lactam therapy active against S. pneumoniae (ie. amoxicillin, amoxicillin-clavulanate, cefprozil, cephalexin, cefadroxil), levofloxacin/moxifloxacin, or doxycycline will not be eligible. Children will not be eligible to participate more than once.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Standard care

No Intervention group

Description:

All participants/caregivers will be asked for consent for point-of-care (POC) blood C-reactive protein (CRP), nasopharyngeal swab for virology/Mycoplasma testing, and urine for pneumococcal antigen (UAg) testing, but, since this testing will not affect care, these are optional (ie. refusal will not preclude enrolment). The RA will phone the caregiver at Day 2-5, Day 14-21, and Day 30 post-enrollment, for outcome ascertainment. Caregivers will be asked to fill out a daily diary (either electronically or on paper) to record the participant's symptoms, clinical progress, and possible drug adverse effects. Caregivers will also be instructed on how to take patient temperature. All participants whose symptoms do not progressively improve will be encouraged to return to the ED to be reassessed, as per standard of care.

Novel Care Pathway

Experimental group

Description:

Once a child is diagnosed with non-severe CAP (community-acquired pneumonia) in the ED, specific radiographic findings and point-of-care CRP testing will identify those who require antibiotic treatment immediately. The next day, results of multiplex respiratory pathogen and urine pneumococcal antigen (UAg, optional) testing will be integrated into the care plan, along with additional clinical information about the child gathered remotely, to ensure that only children at appreciable risk for bacterial infection receive antibiotics. Our care pathway uses already-available testing (NPS) in new ways, integrates newer diagnostics (point-of-care CRP, UAg), and includes properly-timed clinical follow up to change how children with non-severe CAP are managed.The research team will follow-up with the participant and caregiver the next day, 2-5 days, 7-21 days and day 30 post-enrolment to ensure clinical stability.

Treatment:

Other: Novel Care Pathway