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

Community-acquired Pneumonia Clinical Trial

— PIONEER  

Official title:

Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER): a Prospective, Before-after, Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114161
• Other study ID #: HAH-20-12
• Status: Completed
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: April 18, 2024

Study information

• Verified date: April 2024
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: April 18, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Emergencies
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment with antibiotics for community-acquired pneumonia	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)	Day 0-14
Secondary	Clinical cure	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	Day 14-21
Secondary	Re-presentation to the ED	The number of participants in each phase with unscheduled ED visits before day 30 will be compared.	Day 0-30
Secondary	Treatment with broad-spectrum antibiotic therapy for community-acquired pneumonia	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)	Day 0-30
Secondary	Occurence of drug-related adverse events		Day 0-30
Secondary	Development of complicated CAP before day 30	(i.e. pleural effusion or PICU admission)	day 0-30
Secondary	Number of days of missed work (caregiver)		Day 14-21
Secondary	Number of missed days of school/daycare (participant)		Day 14-21
Secondary	Caregiver satisfaction with the care plan	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)	Day of enrolment, day 2-5, day 14-21 and day 30 follow-up
Secondary	Failure to achieve clinical cure in those who have CRP<20 mg/L		Day 0-30
Secondary	Level of serum procalcitonin that effectively rules out the need for antimicrobials	(i.e. the level below which 97.5% of participants experience clinical cure without before prescribed antimicrobials)	Day 0-30
Secondary	Treatment with Mycoplasma-active antibiotics for those in whom Mycoplasma is detected		Day 0-14
Secondary	Unscheduled visits to primary care (eg family MD, nurse practitioner, physician assistant) before day 30 post-enrolment		Day 0-30
Secondary	Hospitalization for CAP		Day 0-30
Secondary	Development of complicated CAP (ie pleural effusion or PICU admission)		Day 0-30