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

NCT ID: NCT06114888

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-17

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Community-acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants randomized to usual care or usual care + diagnostic intervention.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MeMed BV

Group Type EXPERIMENTAL

MeMed BV + Usual Care

Intervention Type 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.

Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care Alone

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Usual Care Alone

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jeffrey

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jeffrey Pernica, MD

Role: CONTACT

Phone: 9055212100

Email: [email protected]

Shamini Selvakumar, MD

Role: CONTACT

Phone: 9055212100

Email: [email protected]

Facility Contacts

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Jeffrey Pernica, MD

Role: primary

Other Identifiers

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HHS-CB 2023-Pernica-1

Identifier Type: -

Identifier Source: org_study_id