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

Not Applicable

Recruiting

• Conditions: Community-acquired Pneumonia
• Interventions: Diagnostic Test: MeMed BV + Usual Care; Other: Usual Care Alone

• Registration Number: NCT06114888
• Lead Sponsor: Jeffrey

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-02
• Study Start: 2024-04-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-11-30
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MeMed BV	MeMed BV + Usual Care	-
Usual Care	Usual Care Alone	-

Primary Outcome Measures

Name	Time	Method
MeMed BV test result reporting	before Day 3	The proportion of participants randomized to MeMed BV testing that have a test result available within 48h of sampling
MeMed BV test timing	before Day 2	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
MeMed BV test result delayed adherence	before Day 15	The proportion of participants (who successfully had their antibiotics stopped) that do not have them restarted specifically for CAP treatment prior to discharge
Losses to followup	before Day 30	The proportion of participants lost to follow-up
Consent success	Day 0	The proportion of potentially eligible participants who consent
MeMed BV test result initial adherence	before Day 4	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

Secondary Outcome Measures

Name	Time	Method
Early clinical response	Day 4	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)
Time to resolution of hypoxaemia	Before discharge
Length of stay in hospital	Before discharge
Acceptability of care plan to caregiver	Day 30
Days of antibiotics given specifically for CAP before hospital discharge	Before discharge
Time to resolution of difficulty breathing	Before discharge
Repeat hospitalization for CAP	After discharge and before day 30
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
Unscheduled primary care visits	After discharge and before day 30
Unscheduled ED or urgent care visits	After discharge and before day 30
Development of complicated pneumonia	Before Day 30	Complicated defined by effusion, empyaema, necrotizing pneumonia

Trial Locations

Locations (1)

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada