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

Last updated: December 8, 2024
Sponsor: Jeffrey
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pneumonia

Pneumonia (Pediatric)

Treatment

MeMed BV + Usual Care

Usual Care Alone

Clinical Study ID

NCT06114888
HHS-CB 2023-Pernica-1
  • Ages 6-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') asper 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 2-4y, 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 withCAP.

Exclusion

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 lobarconsolidation that occupies the majority of a lobe on imaging, a pleural effusionthat occupies more than ¼ of a lung field, or a positive blood culture for abacterial pathogen (not a contaminant). Examples of CAP pathogens include S.pneumoniae, S. pyogenes (group A streptococcus), S. aureus, S. anginosus. Examplesof contaminants that would be ignored include the coagulase-negative staphylococciand Bacillus spp. Children will also be excluded if they have any of the following:chronic lung disease, congenital heart disease (requiring treatment or with exerciserestrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), aseparate episode of pneumonia previously diagnosed within the past 2 weeks, or lungabscess diagnosed within the past six months. Children will not be eligible toparticipate more than once.

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: MeMed BV + Usual Care
Phase:
Study Start date:
April 17, 2024
Estimated Completion Date:
January 01, 2026

Connect with a study center

  • McMaster Children's Hospital

    Hamilton, Ontario L8S 4K1
    Canada

    Active - Recruiting

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