Community-acquired PneumoniaPRESTO-1NCT06114888
Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Novel Diagnostics
A study of Community-acquired Pneumonia, run by Jeffrey Pernica at 1 site in Canada.
Trial summary
Children are commonly hospitalized because of community-acquired pneumonia. Despite the fact that many of these children have viral disease, a majority is treated with antibiotics. These antibiotics will not accelerate recovery in those with viral pneumonia and can cause harm. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Community-acquired Pneumonia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 17 Apr 2024to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') as per the clinical team and who have abnormal chest imaging (eg. radiograph, ultrasound) will be eligible. They must also have at least one of the following:
- documented tachypnoea (>60 bpm for age <1 y, >50 bpm for 1-2 y, >40 bpm for 2-4 y, and >30 bpm for >4 y);
- cough on exam or by history;
- increased work of breathing on exam; or
- auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.
Who cannot join
- Children will be excluded from if they have received >48h of intravenous antibiotics (eg. if transferred from another healthcare facility) or if they have a lobar consolidation that occupies the majority of a lobe on imaging, a pleural effusion that occupies more than ¼ of a lung field, or a positive blood culture for a bacterial pathogen (not a contaminant). Examples of CAP pathogens include S. pneumoniae, S. pyogenes (group A streptococcus), S. aureus, S. anginosus. Examples of contaminants that would be ignored include the coagulase-negative staphylococci and Bacillus spp. Children will also be excluded if they have any of the following: chronic lung disease, congenital heart disease (requiring treatment or with exercise restrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), a separate episode of pneumonia previously diagnosed within the past 2 weeks, or lung abscess diagnosed within the past six months. Children will not be eligible to participate more than once.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1
Jeffrey Pernica, MD, 9055212100 ext. 77577, pernica@mcmaster.ca
About this study
Official title: Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of a Diagnostic Intervention
Children are commonly hospitalized because of community-acquired pneumonia. Despite the fact that many of these children have viral disease, a majority is treated with antibiotics. These antibiotics will not accelerate recovery in those with viral pneumonia and can cause harm. We are interested in exploring whether the MeMed BV - a composite biomarker assay - could be used to improve antibiotic prescribing in these children by identifying those who likely have viral disease. This proposal describes a feasibility randomized trial of this diagnostic intervention.
- Conditions
- Community-acquired Pneumonia
- Being tested
- MeMed BV + Usual Care, Usual Care Alone
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeMed BV + Usual CareDiagnostic test
We will aim to have blood drawn for MeMed BV testing within 24 hours of the first dose of IV antibiotics. We will then aim to have test results back within 24 hours of sampling.
Usual Care AloneOther
Usual care can involve oxygenation support, ventilatory support, intravenous fluids, and antibiotics, or any combination of these.
| Study group | Role | What they receive |
|---|---|---|
| MeMed BV | Experimental | Not described Receives: Diagnostic Test: MeMed BV + Usual Care |
| Usual Care | Active comparator | Not described Receives: Other: Usual Care Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent success
The proportion of potentially eligible participants who consent
Measured: Day 0
MeMed BV test timing
The proportion of participants randomized to the diagnostic intervention who successfully have the MeMed BV performed within 24 h of receipt of the initial dose of IV antibiotics
Measured: before Day 2
MeMed BV test result reporting
The proportion of participants randomized to MeMed BV testing that have a test result available within 48h of sampling
Measured: before Day 3
MeMed BV test result initial adherence
The proportion of participants found to be high risk for viral infection that successfully have their antibiotics stopped within 24 hours of the test result becoming available
Measured: before Day 4
MeMed BV test result delayed adherence
The proportion of participants (who successfully had their antibiotics stopped) that do not have them restarted specifically for CAP treatment prior to discharge
Measured: before Day 15
Losses to followup
The proportion of participants lost to follow-up
Measured: before Day 30
Secondary outcomes (13)
Early clinical response
This is defined as:
- clinical improvement in fever, work of breathing, oral intake, and activity level, AND ii) lack of receipt of additional antimicrobials beyond those already being given at baseline (for the control group) or as indicated by MeMed BV testing (for those randomized to the intervention group)
Measured: Day 4
Days of antibiotics given specifically for CAP before hospital discharge
Measured: Before discharge
Days of antibiotics given specifically for CAP after hospital discharge and before day 30
Measured: after hospital discharge and before day 30
Time to resolution of fever
Measured: Before discharge
Time to resolution of difficulty breathing
Measured: Before discharge
Time to resolution of hypoxaemia
Measured: Before discharge
Length of stay in hospital
Measured: Before discharge
Repeat hospitalization for CAP
Measured: After discharge and before day 30
Unscheduled ED or urgent care visits
Measured: After discharge and before day 30
Unscheduled primary care visits
Measured: After discharge and before day 30
Development of complicated pneumonia
Complicated defined by effusion, empyaema, necrotizing pneumonia
Measured: Before Day 30
Acceptability of care plan to caregiver
Measured: Baseline
Acceptability of care plan to caregiver
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start17 Apr 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to usual care or usual care + diagnostic intervention.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeffrey Pernica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey Pernica, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114888
- Sponsor's protocol ID
- HHS-CB 2023-Pernica-1
- Acronym
- PRESTO-1
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of a Diagnostic Intervention
- ClinicalTrials.gov ID
- NCT06114888
- Acronym / sponsor ID
- PRESTO-1 / HHS-CB 2023-Pernica-1
- Conditions
- Community-acquired Pneumonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Jeffrey PernicaUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 2 Nov 2023 (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.
Children are commonly hospitalized because of community-acquired pneumonia. Despite the fact that many of these children have viral disease, a majority is treated with antibiotics. These antibiotics will not accelerate recovery in those with viral pneumonia and can cause harm. We are interested in exploring whether the MeMed BV - a composite biomarker assay - could be used to improve antibiotic prescribing in these children by identifying those who likely have viral disease. This proposal describes a feasibility randomized trial of this diagnostic intervention.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants randomized to usual care or usual care + diagnostic intervention.
| Arm | Type | Receives |
|---|---|---|
| MeMed BV | Experimental | Diagnostic Test: MeMed BV + Usual Care |
| Usual Care | Active comparator | Other: Usual Care Alone |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') as per the clinical team and who have abnormal chest imaging (eg. radiograph, ultrasound) will be eligible. They must also have at least one of the following:
Key exclusion criteria (1 listed)
- Children will be excluded from if they have received >48h of intravenous antibiotics (eg. if transferred from another healthcare facility) or if they have a lobar consolidation that occupies the majority of a lobe on imaging, a pleural effusion that occupies more than ¼ of a lung field, or a positive blood culture for a bacterial pathogen (not a contaminant). Examples of CAP pathogens include S. pneumoniae, S. pyogenes (group A streptococcus), S. aureus, S. anginosus. Examples of contaminants that would be ignored include the coagulase-negative staphylococci and Bacillus spp. Children will also be excluded if they have any of the following: chronic lung disease, congenital heart disease (requiring treatment or with exercise restrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), a separate episode of pneumonia previously diagnosed within the past 2 weeks, or lung abscess diagnosed within the past six months. 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 |
|---|---|---|
| MeMed BV + Usual CareWe will aim to have blood drawn for MeMed BV testing within 24 hours of the first dose of IV antibiotics. We will then aim to have test results back within 24 hours of sampling. | Diagnostic test | MeMed BV |
| Usual Care AloneUsual care can involve oxygenation support, ventilatory support, intravenous fluids, and antibiotics, or any combination of these. | Other | Usual Care |
Primary outcome
Consent success
Time frame: Day 0
The proportion of potentially eligible participants who consent
MeMed BV test timing
Time frame: before Day 2
The proportion of participants randomized to the diagnostic intervention who successfully have the MeMed BV performed within 24 h of receipt of the initial dose of IV antibiotics
MeMed BV test result reporting
Time frame: before Day 3
The proportion of participants randomized to MeMed BV testing that have a test result available within 48h of sampling
MeMed BV test result initial adherence
Time frame: before Day 4
The proportion of participants found to be high risk for viral infection that successfully have their antibiotics stopped within 24 hours of the test result becoming available
MeMed BV test result delayed adherence
Time frame: before Day 15
The proportion of participants (who successfully had their antibiotics stopped) that do not have them restarted specifically for CAP treatment prior to discharge
Losses to followup
Time frame: before Day 30
The proportion of participants lost to follow-up
13 secondary outcomes
Early clinical response
Time frame: Day 4
Days of antibiotics given specifically for CAP before hospital discharge
Time frame: Before discharge
Days of antibiotics given specifically for CAP after hospital discharge and before day 30
Time frame: after hospital discharge and before day 30
Time to resolution of fever
Time frame: Before discharge
Time to resolution of difficulty breathing
Time frame: Before discharge
Time to resolution of hypoxaemia
Time frame: Before discharge
Length of stay in hospital
Time frame: Before discharge
Repeat hospitalization for CAP
Time frame: After discharge and before day 30
Unscheduled ED or urgent care visits
Time frame: After discharge and before day 30
Unscheduled primary care visits
Time frame: After discharge and before day 30
Development of complicated pneumonia
Time frame: Before Day 30
Acceptability of care plan to caregiver
Time frame: Baseline
Acceptability of care plan to caregiver
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Community-acquired Pneumonia, run by Jeffrey Pernica 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 5 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Pernica, MD (9055212100 ext. 77577, pernica@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent success (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.