Community-acquired PneumoniaPIONEERNCT05114161
Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER)
A study testing Novel Care Pathway in people with Community-acquired Pneumonia, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Novel Care Pathway
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteCanada
- Study dates
- 14 Feb 2022to 18 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER): a Prospective, Before-after, Cohort Study
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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Novel Care Pathway
- Keywords
- Community-Acquired Pneumonia, Diagnostics, Respiratory Viruses, Mycoplasma
- Medical subject headings
- Community-Acquired Pneumonia, Mycoplasma Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Care PathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | 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 | 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. Receives: Other: Novel Care Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 0-14
Secondary outcomes (14)
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
Measured: Day 14-21
Re-presentation to the ED
The number of participants in each phase with unscheduled ED visits before day 30 will be compared.
Measured: Day 0-30
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)
Measured: Day 0-30
Occurence of drug-related adverse events
Measured: Day 0-30
Development of complicated CAP before day 30
(i.e. pleural effusion or PICU admission)
Measured: day 0-30
Number of days of missed work (caregiver)
Measured: Day 14-21
Number of missed days of school/daycare (participant)
Measured: Day 14-21
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)
Measured: Day of enrolment, day 2-5, day 14-21 and day 30 follow-up
Failure to achieve clinical cure in those who have CRP<20 mg/L
Measured: Day 0-30
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)
Measured: Day 0-30
Treatment with Mycoplasma-active antibiotics for those in whom Mycoplasma is detected
Measured: Day 0-14
Unscheduled visits to primary care (eg family MD, nurse practitioner, physician assistant) before day 30 post-enrolment
Measured: Day 0-30
Hospitalization for CAP
Measured: Day 0-30
Development of complicated CAP (ie pleural effusion or PICU admission)
Measured: Day 0-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start14 Feb 2022
- Primary completion30 Mar 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Before-after study
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Pernica, Hamilton Health Sciences Corporation
- Investigators
- Jeffrey Pernica, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114161
- Sponsor's protocol ID
- HAH-20-12
- Acronym
- PIONEER
- Status last verified
- Apr 2024
- First submitted
- 18 Oct 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data relating to the primary outcome will be made available upon reasonable request.
Publications
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.
PubMed 36396301
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER): a Prospective, Before-after, Cohort Study
- ClinicalTrials.gov ID
- NCT05114161
- Acronym / sponsor ID
- PIONEER / HAH-20-12
- Conditions
- Community-acquired Pneumonia
- Keywords
- Community-Acquired Pneumonia, Diagnostics, Respiratory Viruses, Mycoplasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before-after study
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –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 | Other: Novel Care PathwayOnce 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. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Care PathwayThe 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. | Other | Novel Care Pathway |
Primary outcome
Treatment with antibiotics for community-acquired pneumonia
Time frame: 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)
14 secondary outcomes
Clinical cure
Time frame: Day 14-21
Re-presentation to the ED
Time frame: Day 0-30
Treatment with broad-spectrum antibiotic therapy for community-acquired pneumonia
Time frame: Day 0-30
Occurence of drug-related adverse events
Time frame: Day 0-30
Development of complicated CAP before day 30
Time frame: day 0-30
Number of days of missed work (caregiver)
Time frame: Day 14-21
Number of missed days of school/daycare (participant)
Time frame: Day 14-21
Caregiver satisfaction with the care plan
Time frame: Day of enrolment, day 2-5, day 14-21 and day 30 follow-up
Failure to achieve clinical cure in those who have CRP<20 mg/L
Time frame: Day 0-30
Level of serum procalcitonin that effectively rules out the need for antimicrobials
Time frame: Day 0-30
Treatment with Mycoplasma-active antibiotics for those in whom Mycoplasma is detected
Time frame: Day 0-14
Unscheduled visits to primary care (eg family MD, nurse practitioner, physician assistant) before day 30 post-enrolment
Time frame: Day 0-30
Hospitalization for CAP
Time frame: Day 0-30
Development of complicated CAP (ie pleural effusion or PICU admission)
Time frame: Day 0-30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 36396301Pernica 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.
- Individual participant dataSharing planned: Yes. Data relating to the primary outcome will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Pernica, MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Care Pathway in people with Community-acquired Pneumonia, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment with antibiotics for community-acquired pneumonia (time frame: Day 0-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05114161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.