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

NCT06114888 | Recruiting

• 1 other identifier: HHS-CB 2023-Pernica-1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (6)

• Consent success

  The proportion of potentially eligible participants who consent

  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

  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

  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

  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

  before Day 15

• Losses to followup

  The proportion of participants lost to follow-up

  before Day 30

Secondary Outcomes (13)

• Early clinical response

  Day 4

• Days of antibiotics given specifically for CAP before hospital discharge

  Before discharge

• Days of antibiotics given specifically for CAP after hospital discharge and before day 30

  after hospital discharge and before day 30

• Time to resolution of fever

  Before discharge

• Time to resolution of difficulty breathing

  Before discharge

Study Arms (2)

MeMed BV

EXPERIMENTAL

Diagnostic Test: MeMed BV + Usual Care

Usual Care

ACTIVE COMPARATOR

Other: Usual Care Alone

Interventions

MeMed BV + Usual Care DIAGNOSTIC_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.

MeMed BV

Usual Care Alone OTHER

Usual care can involve oxygenation support, ventilatory support, intravenous fluids, and antibiotics, or any combination of these.

Usual Care

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeffrey: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Central Study Contacts

Jeffrey Pernica, MD

CONTACT

9055212100; pernica@mcmaster.ca

Shamini Selvakumar, MD

CONTACT

9055212100; selvaks@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants randomized to usual care or usual care + diagnostic intervention.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 2, 2023
• Study Start: April 17, 2024
• Primary Completion: November 30, 2025
• Study Completion: January 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CA (1)