Recruiting

MeMed BV

Sponsor:

Jeffrey

Code:

NCT06114888

Conditions

Community-acquired Pneumonia

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

MeMed BV + Usual Care

Usual Care Alone

Study Details

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

Study ID

NCT06114888

Start date

Apr 17, 2024

Status verified date

Dec, 2024

Completion date

Jan 1, 2026

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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 ΒΌ 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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: MeMed BV

active comparator: Usual Care

Interventions

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.

Usual Care Alone

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

Primary outcome measure

  • Consent success [ Time Frame: Day 0 ]
  • MeMed BV test timing [ Time Frame: before Day 2 ]
  • MeMed BV test result reporting [ Time Frame: before Day 3 ]
  • MeMed BV test result initial adherence [ Time Frame: before Day 4 ]
  • MeMed BV test result delayed adherence [ Time Frame: before Day 15 ]
  • Losses to followup [ Time Frame: before Day 30 ]

Central Contacts and Locations

Central contacts

Jeffrey Pernica, MD

9055212100pernica@mcmaster.ca

Shamini Selvakumar, MD

9055212100selvaks@mcmaster.ca

Locations

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

Jeffrey Pernica, MD

9055212100pernica@mcmaster.ca

More Information

Sponsor

Jeffrey

Last update posted

Dec 10, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jeffrey on 2024-12-10.