Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER)
- Conditions
- Community-acquired Pneumonia
- Interventions
- Other: Novel Care Pathway
- Registration Number
- NCT05114161
- Lead Sponsor
- Hamilton Health Sciences Corporation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
-
Diagnosed primarily with community-acquired pneumonia as per the ED MD and are well enough to be discharged home.
-
They also must have any one of:
- tachypnoea;
- cough;
- increased work of breathing; or
- auscultatory findings consistent with pneumonia;
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Novel Care Pathway Novel Care Pathway 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.
- Primary Outcome Measures
Name Time Method Treatment with antibiotics for community-acquired pneumonia Day 0-14 The proportion of participants who receive antibiotics specifically targeting community-acquired pneumonia will be assessed at follow-up visits (as per participant caregiver report) and compared between phases of the study (control phase and intervention phase)
- Secondary Outcome Measures
Name Time Method Level of serum procalcitonin that effectively rules out the need for antimicrobials Day 0-30 (i.e. the level below which 97.5% of participants experience clinical cure without before prescribed antimicrobials)
Hospitalization for CAP Day 0-30 Treatment with broad-spectrum antibiotic therapy for community-acquired pneumonia Day 0-30 The proportion of participants who receive broad-spectrum antibiotics (ie. amoxicillin/clavulanate, cephalosporins, azithromycin, fluoroquinolones) specifically targeting community-acquired pneumonia will be assessed at follow-up visits (as per participant caregiver report) and compared between phases of the study (control phase and intervention phase)
Occurence of drug-related adverse events Day 0-30 Caregiver satisfaction with the care plan Day of enrolment, day 2-5, day 14-21 and day 30 follow-up This will be measured using a previously validated scale (Likert scale evaluating satisfaction with each of: overall care, doctor's diagnosis, and antibiotic treatment plan)
Development of complicated CAP (ie pleural effusion or PICU admission) Day 0-30 Clinical cure Day 14-21 Cure defined by 1) symptoms improving as per caregiver report, 2) failure to be hospitalized for community-acquired pneumonia, and 3) lack of receipt of additional antimicrobials specifically for the treatment of community-acquired pneumonia
Number of missed days of school/daycare (participant) Day 14-21 Re-presentation to the ED Day 0-30 The number of participants in each phase with unscheduled ED visits before day 30 will be compared.
Failure to achieve clinical cure in those who have CRP<20 mg/L Day 0-30 Treatment with Mycoplasma-active antibiotics for those in whom Mycoplasma is detected Day 0-14 Number of days of missed work (caregiver) Day 14-21 Development of complicated CAP before day 30 day 0-30 (i.e. pleural effusion or PICU admission)
Unscheduled visits to primary care (eg family MD, nurse practitioner, physician assistant) before day 30 post-enrolment Day 0-30
Trial Locations
- Locations (1)
McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada