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Completed

NCT Number: NCT03932942

Point-of-care Testing of Respiratory Pathogens at Pediatric Emergency Room

The main objective of the trial is to evaluate the effect of point-of-care testing of respiratory pathogens at a pediatric emergency room on the antibiotic consumption and hospital admissions in acutely ill children.

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Key information

Conditions

Respiratory Tract Infections Disease Attributes Emergencies Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatrics, Oulu University Hospital

Oulu, 90014, Finland

About this study

The study is a randomized controlled trial including children 0 up to 17 years of age with fever or acute respiratory infection at a pediatric emergency department in university hospital. In total 1668 subjects will be randomly allocated to undergo point-of-care multiplex respiratory pathogen testing with results ready within approximately one hour or to a control group with testing according to clinical judgement and results ready within next office day. Subjects will be randomized on admission and unequal allocation ratio of 2:1 (1112 subjects to intervention and 556 subjects to control arm) will be used. Data on rate of hospitalization, antibiotic prescriptions, ancillary testing and length of visit will be collected using medical record system.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any respiratory symptom defined as tachypnea, shortness of breath, apnea, wheezing, cough, rhinitis, croup, sneezing, ear ache, or sore throat AND/OR
  • Fever > 38.0 C

Exclusion criteria

  • Need of resuscitation at emergency room
  • Need of immediate transfer to pediatric intensive care unit

Treatment and study plan

QIAstat at pediatric emergency room

Diagnostic Test

Pediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom.

Primary outcomes

  1. Proportion of children with antibiotic prescription at emergency room

    Time frame: Up to 1 day after study entry

    Antibiotic consumption at emergency room

Secondary outcomes

  1. Proportion of children with antibiotics in one week

    Time frame: 0-7 days after study entry

    Antimicrobial prescription rate

  2. Proportion of children receiving macrolide antibiotic at pediatric emergency room

    Time frame: Up to 1 day after study entry

    Among all children randomized

  3. Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room

    Time frame: Up to 1 day after study entry

    Among all children randomized

  4. Proportion of children admitted to hospital

    Time frame: Up to 1 day after study entry

    Hospital admissions

  5. Proportion of children admitted to hospital

    Time frame: 0-7 days after study entry

    Hospital admissions

  6. Number of other diagnostic tests than point-of-care test performed at emergency room

    Time frame: Up to 1 day after study entry

    Number and cost of diagnostic tests such as blood culture, blood chemistry

  7. Proportion of children with readmission to hospital or revisit at emergency room

    Time frame: 0-7 days after study entry

    Proportion of children with hospital readmission or emergency room revisit within 7 days after discharge from ED or hospital

  8. Proportion of children with outpatient telephone contact within 7 days after discharge from emergency room

    Time frame: 0-7 days

    Outpatient telephone contact within 7 days after discharge from emergency room

  9. Number of diagnostic tests per child other than point-of-care test performed within one week

    Time frame: 0-7 days after discharge

    Ancillary laboratory testing

  10. Proportion of children with admission to pediatric intensive care unit or intensive care unit

    Time frame: 0-30 days

    Admission to pediatric intensive care unit or intensive care unit

  11. Proportion of children who died within one month after study entry

    Time frame: 0-30 days

    Mortality

  12. Cost in euros per child per visits

    Time frame: 0-7 days after study entry

    Visit associated cost (euros)

  13. Length of stay at emergency room in minutes

    Time frame: Up to 1 day after study entry

    Mean length of visit at emergency room (minutes)

  14. Proportion of children receiving correct pathogen directed therapy

    Time frame: 0-7 days after study entry

    Antimicrobial use for Mycoplasma pneumoniae, pertussis and influenza

  15. Time to initiation of correct pathogen directed therapy

    Time frame: 0-7 days after study entry

    Antimicrobials for Mycoplasma pneumoniae, pertussis and influenza (minutes)

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Oulu University Hospital

Registry information

Official study title

Impact of Multiplex Respiratory Pathogen Testing on Antimicrobial Consumption and Hospital Admissions at Pediatric Emergency Room: A Randomized Controlled Trial

Acronym: Hevi-RCT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 1, 2019
Registry last updated
Nov 4, 2020

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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