Clinical trial NCT05114161: Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER)
Official title: Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER): a Prospective, Before-after, Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: Community-Acquired Pneumonia
Diagnostics
Respiratory Viruses
Mycoplasma
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 162
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Before-after study
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment with antibiotics for community-acquired pneumonia
timeFrame: Day 0-14
Secondary outcomes:
measure: Clinical cure
timeFrame: Day 14-21
measure: Re-presentation to the ED
timeFrame: Day 0-30
measure: Treatment with broad-spectrum antibiotic therapy for community-acquired pneumonia
timeFrame: Day 0-30
measure: Occurence of drug-related adverse events
timeFrame: Day 0-30
measure: Development of complicated CAP before day 30
timeFrame: day 0-30
measure: Number of days of missed work (caregiver)
timeFrame: Day 14-21
measure: Number of missed days of school/daycare (participant)
timeFrame: Day 14-21
measure: Caregiver satisfaction with the care plan
timeFrame: Day of enrolment, day 2-5, day 14-21 and day 30 follow-up
measure: Failure to achieve clinical cure in those who have CRP<20 mg/L
timeFrame: Day 0-30
measure: Level of serum procalcitonin that effectively rules out the need for antimicrobials
timeFrame: Day 0-30
measure: Treatment with Mycoplasma-active antibiotics for those in whom Mycoplasma is detected
timeFrame: Day 0-14
measure: Unscheduled visits to primary care (eg family MD, nurse practitioner, physician assistant) before day 30 post-enrolment
timeFrame: Day 0-30
measure: Hospitalization for CAP
timeFrame: Day 0-30
measure: Development of complicated CAP (ie pleural effusion or PICU admission)
timeFrame: Day 0-30
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Jeffrey Pernica, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pernica JM, Kam AJ, Eltorki M, Khan S, Goldfarb DM, Smaill F, Wong J, Ewusie J, Smieja M, Sung M, Mertz D, Thabane L, Loeb M. Novel care pathway to optimise antimicrobial prescribing for uncomplicated community-acquired pneumonia: study protocol for a prospective before-after cohort study in the emergency department of a tertiary care Canadian children's hospital. BMJ Open. 2022 Nov 17;12(11):e062360. doi: 10.1136/bmjopen-2022-062360.