Back to resultsPromoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER) (PIONEER)
Primary Purpose
Community-acquired Pneumonia
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Novel Care Pathway
Sponsored by
About this trial
This is an interventional diagnostic trial for Community-acquired Pneumonia focused on measuring Community-Acquired Pneumonia, Diagnostics, Respiratory Viruses, Mycoplasma
Eligibility Criteria
Inclusion Criteria:
- 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;
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.
Sites / Locations
- McMaster Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
Novel Care Pathway
Arm 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.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Re-presentation to the ED
The number of participants in each phase with unscheduled ED visits before day 30 will be compared.
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)
Occurence of drug-related adverse events
Development of complicated CAP before day 30
(i.e. pleural effusion or PICU admission)
Number of days of missed work (caregiver)
Number of missed days of school/daycare (participant)
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)
Failure to achieve clinical cure in those who have CRP<20 mg/L
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)
Treatment with Mycoplasma-active antibiotics for those in whom Mycoplasma is detected
Unscheduled visits to primary care (eg family MD, nurse practitioner, physician assistant) before day 30 post-enrolment
Hospitalization for CAP
Development of complicated CAP (ie pleural effusion or PICU admission)
Full Information
NCT ID
NCT05114161
First Posted
October 18, 2021
Last Updated
September 20, 2023
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05114161
Brief Title
Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER)
Acronym
PIONEER
Official Title
Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER): a Prospective, Before-after, Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
Community-Acquired Pneumonia, Diagnostics, Respiratory Viruses, Mycoplasma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Before-after study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm 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.
Arm Title
Novel Care Pathway
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Novel Care Pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment with antibiotics for community-acquired pneumonia
Description
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)
Time Frame
Day 0-14
Secondary Outcome Measure Information:
Title
Clinical cure
Description
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
Time Frame
Day 14-21
Title
Re-presentation to the ED
Description
The number of participants in each phase with unscheduled ED visits before day 30 will be compared.
Time Frame
Day 0-30
Title
Treatment with broad-spectrum antibiotic therapy for community-acquired pneumonia
Description
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)
Time Frame
Day 0-30
Title
Occurence of drug-related adverse events
Time Frame
Day 0-30
Title
Development of complicated CAP before day 30
Description
(i.e. pleural effusion or PICU admission)
Time Frame
day 0-30
Title
Number of days of missed work (caregiver)
Time Frame
Day 14-21
Title
Number of missed days of school/daycare (participant)
Time Frame
Day 14-21
Title
Caregiver satisfaction with the care plan
Description
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)
Time Frame
Day of enrolment, day 2-5, day 14-21 and day 30 follow-up
Title
Failure to achieve clinical cure in those who have CRP<20 mg/L
Time Frame
Day 0-30
Title
Level of serum procalcitonin that effectively rules out the need for antimicrobials
Description
(i.e. the level below which 97.5% of participants experience clinical cure without before prescribed antimicrobials)
Time Frame
Day 0-30
Title
Treatment with Mycoplasma-active antibiotics for those in whom Mycoplasma is detected
Time Frame
Day 0-14
Title
Unscheduled visits to primary care (eg family MD, nurse practitioner, physician assistant) before day 30 post-enrolment
Time Frame
Day 0-30
Title
Hospitalization for CAP
Time Frame
Day 0-30
Title
Development of complicated CAP (ie pleural effusion or PICU admission)
Time Frame
Day 0-30
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Genders eligible for Study: All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Pernica
Phone
905-521-2100
Ext
77577
Email
pernica@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Pernica, MD
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Pernica, MD
First Name & Middle Initial & Last Name & Degree
Jeffrey Pernica, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data relating to the primary outcome will be made available upon reasonable request.
IPD Sharing Time Frame
Protocol and SAP will be available after their publication. Outcome data will be made available after study completion and publication.
Citations:
PubMed Identifier
36396301
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.
Results Reference
derived
Learn more about this trial
Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER)
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