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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Diagnostic Test: QIAstat at pediatric emergency room


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial 2:1
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Point-of-care testing of respiratory pathogens on admission<br>Point-of-care testing of respiratory pathogens on admission. The subjects will receive the point-of-care testing of respiratory pathogens at pediatric emergency room. The results are ready within 1 one hour. | Diagnostic Test: QIAstat at pediatric emergency room<br>* Pediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom.<br>|
| No Intervention: Routine ED protocol<br>Diagnostic tests for respiratory pathogens will be obtained according to clinical judgement and tested on microbiological laboratory. The results are ready on the next office day. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of children with antibiotic prescription at emergency room | Antibiotic consumption at emergency room | Up to 1 day after study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of children with antibiotics in one week | Antimicrobial prescription rate | 0-7 days after study entry | 
| Proportion of children receiving macrolide antibiotic at pediatric emergency room | Among all children randomized | Up to 1 day after study entry | 
| Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room | Among all children randomized | Up to 1 day after study entry | 
| Proportion of children admitted to hospital | Hospital admissions | Up to 1 day after study entry | 
| Proportion of children admitted to hospital | Hospital admissions | 0-7 days after study entry | 
| Number of other diagnostic tests than point-of-care test performed at emergency room | Number and cost of diagnostic tests such as blood culture, blood chemistry | Up to 1 day after study entry | 
| Proportion of children with readmission to hospital or revisit at emergency room | Proportion of children with hospital readmission or emergency room revisit within 7 days after discharge from ED or hospital | 0-7 days after study entry | 
| Proportion of children with outpatient telephone contact within 7 days after discharge from emergency room | Outpatient telephone contact within 7 days after discharge from emergency room | 0-7 days | 
| Number of diagnostic tests per child other than point-of-care test performed within one week | Ancillary laboratory testing | 0-7 days after discharge | 
| Proportion of children with admission to pediatric intensive care unit or intensive care unit | Admission to pediatric intensive care unit or intensive care unit | 0-30 days | 
| Proportion of children who died within one month after study entry | Mortality | 0-30 days | 
| Cost in euros per child per visits | Visit associated cost (euros) | 0-7 days after study entry | 
| Length of stay at emergency room in minutes | Mean length of visit at emergency room (minutes) | Up to 1 day after study entry | 
| Proportion of children receiving correct pathogen directed therapy | Antimicrobial use for Mycoplasma pneumoniae, pertussis and influenza | 0-7 days after study entry | 
| Time to initiation of correct pathogen directed therapy | Antimicrobials for Mycoplasma pneumoniae, pertussis and influenza (minutes) | 0-7 days after study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency room, Anti-bacterial agents, Respiratory pathogen, Point-of-care testing, Patient admission, Pediatrics, Pediatric emergency medicine, Cost-benefit analysis, Antimicrobial stewardship