Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Novel Diagnostics

Community-acquired Pneumonia Clinical Trial

— PRESTO-1  

Official title:

Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of a Diagnostic Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06114888
• Other study ID #: HHS-CB 2023-Pernica-1
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: Hamilton Health Sciences Corporation
• Contact: Jeffrey Pernica, MD
• Phone: 9055212100
• Email: pernica[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 1, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• 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:

1. 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);

2. cough on exam or by history;

3. increased work of breathing on exam; or

4. auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Diagnostic Test:
• MeMed BV + Usual Care
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.

Other:
• Usual Care Alone
Usual care can involve oxygenation support, ventilatory support, intravenous fluids, and antibiotics, or any combination of these.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jeffrey Pernica

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consent success	The proportion of potentially eligible participants who consent	Day 0
Primary	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	before Day 2
Primary	MeMed BV test result reporting	The proportion of participants randomized to MeMed BV testing that have a test result available within 48h of sampling	before Day 3
Primary	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	before Day 4
Primary	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	before Day 15
Primary	Losses to followup	The proportion of participants lost to follow-up	before Day 30
Secondary	Early clinical response	This is defined as: i) 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)	Day 4
Secondary	Days of antibiotics given specifically for CAP before hospital discharge		Before discharge
Secondary	Days of antibiotics given specifically for CAP after hospital discharge and before day 30		after hospital discharge and before day 30
Secondary	Time to resolution of fever		Before discharge
Secondary	Time to resolution of difficulty breathing		Before discharge
Secondary	Time to resolution of hypoxaemia		Before discharge
Secondary	Length of stay in hospital		Before discharge
Secondary	Repeat hospitalization for CAP		After discharge and before day 30
Secondary	Unscheduled ED or urgent care visits		After discharge and before day 30
Secondary	Unscheduled primary care visits		After discharge and before day 30
Secondary	Development of complicated pneumonia	Complicated defined by effusion, empyaema, necrotizing pneumonia	Before Day 30
Secondary	Acceptability of care plan to caregiver		Baseline
Secondary	Acceptability of care plan to caregiver		Day 30