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Recruiting NCT06114888

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

No phase Interventional Community-acquired Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MeMed BV + Usual Care, Usual Care Alone.
Who it may be relevant to
Registry conditions: Community-acquired Pneumonia. Basic parameters: 6 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of a Diagnostic Intervention

Overview

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.

Interventions

  • Diagnostic test 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.
  • Other Usual Care Alone
    Usual care can involve oxygenation support, ventilatory support, intravenous fluids, and antibiotics, or any combination of these.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Early clinical response [Time frame: Day 4]
  • Days of antibiotics given specifically for CAP before hospital discharge [Time frame: Before discharge]
  • Days of antibiotics given specifically for CAP after hospital discharge and before day 30 [Time frame: after hospital discharge and before day 30]
  • Time to resolution of fever [Time frame: Before discharge]
  • Time to resolution of difficulty breathing [Time frame: Before discharge]
  • Time to resolution of hypoxaemia [Time frame: Before discharge]
  • Length of stay in hospital [Time frame: Before discharge]
  • Repeat hospitalization for CAP [Time frame: After discharge and before day 30]
  • Unscheduled ED or urgent care visits [Time frame: After discharge and before day 30]
  • Unscheduled primary care visits [Time frame: After discharge and before day 30]
  • Development of complicated pneumonia [Time frame: Before Day 30]
  • Acceptability of care plan to caregiver [Time frame: Baseline]

Eligibility criteria

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:
  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Canada · 1 center
  • McMaster Children's Hospital — Hamilton

Identifiers

NCT: NCT06114888 · HHS-CB 2023-Pernica-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗