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NCT Number: NCT06114888

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

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.

Recruiting

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Key information

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

Location status: Recruiting

Location contact

Jeffrey Pernica, MD

CONTACT

[email protected]

9055212100 ext. 77577

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MeMed BV + Usual Care

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 Alone

Other

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

Primary outcomes

  1. Consent success

    Time frame: Day 0

    The proportion of potentially eligible participants who consent

  2. MeMed BV test timing

    Time frame: 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

  3. MeMed BV test result reporting

    Time frame: before Day 3

    The proportion of participants randomized to MeMed BV testing that have a test result available within 48h of sampling

  4. MeMed BV test result initial adherence

    Time frame: 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

  5. MeMed BV test result delayed adherence

    Time frame: 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

  6. Losses to followup

    Time frame: before Day 30

    The proportion of participants lost to follow-up

Secondary outcomes

  1. Early clinical response

    Time frame: 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)

  2. Days of antibiotics given specifically for CAP before hospital discharge

    Time frame: Before discharge

  3. Days of antibiotics given specifically for CAP after hospital discharge and before day 30

    Time frame: after hospital discharge and before day 30

  4. Time to resolution of fever

    Time frame: Before discharge

  5. Time to resolution of difficulty breathing

    Time frame: Before discharge

  6. Time to resolution of hypoxaemia

    Time frame: Before discharge

  7. Length of stay in hospital

    Time frame: Before discharge

  8. Repeat hospitalization for CAP

    Time frame: After discharge and before day 30

  9. Unscheduled ED or urgent care visits

    Time frame: After discharge and before day 30

  10. Unscheduled primary care visits

    Time frame: After discharge and before day 30

  11. Development of complicated pneumonia

    Time frame: Before Day 30

    Complicated defined by effusion, empyaema, necrotizing pneumonia

  12. Acceptability of care plan to caregiver

    Time frame: Baseline

  13. Acceptability of care plan to caregiver

    Time frame: Day 30

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey Pernica, MD

CONTACT

[email protected]

9055212100 ext. 77577

Shamini Selvakumar, MD

CONTACT

[email protected]

9055212100

Sponsors and collaborators

Lead sponsor

Jeffrey

Other

Registry information

Official study title

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

Acronym: PRESTO-1

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 2, 2023
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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