Clinical trial NCT06114888: Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Novel Diagnostics
Official title: Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of a Diagnostic Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Community-acquired Pneumonia
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized to usual care or usual care + diagnostic intervention.
Primary purpose: DIAGNOSTIC

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.


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:

  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.

Primary outcomes:
measure: Consent success
timeFrame: Day 0
measure: MeMed BV test timing
timeFrame: before Day 2
measure: MeMed BV test result reporting
timeFrame: before Day 3
measure: MeMed BV test result initial adherence
timeFrame: before Day 4
measure: MeMed BV test result delayed adherence
timeFrame: before Day 15
measure: Losses to followup
timeFrame: before Day 30
Secondary outcomes:
measure: Early clinical response
timeFrame: Day 4
measure: Days of antibiotics given specifically for CAP before hospital discharge
timeFrame: Before discharge
measure: Days of antibiotics given specifically for CAP after hospital discharge and before day 30
timeFrame: after hospital discharge and before day 30
measure: Time to resolution of fever
timeFrame: Before discharge
measure: Time to resolution of difficulty breathing
timeFrame: Before discharge
measure: Time to resolution of hypoxaemia
timeFrame: Before discharge
measure: Length of stay in hospital
timeFrame: Before discharge
measure: Repeat hospitalization for CAP
timeFrame: After discharge and before day 30
measure: Unscheduled ED or urgent care visits
timeFrame: After discharge and before day 30
measure: Unscheduled primary care visits
timeFrame: After discharge and before day 30
measure: Development of complicated pneumonia
timeFrame: Before Day 30
measure: Acceptability of care plan to caregiver
timeFrame: Baseline
measure: Acceptability of care plan to caregiver
timeFrame: Day 30
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
References: