Respiratory Tract Infections
Conditions
Keywords
Anti-bacterial agents, Emergency room, Respiratory pathogen, Point-of-care testing, Patient admission, Pediatrics, Pediatric emergency medicine, Cost-benefit analysis, Antimicrobial stewardship
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTQIAstat at pediatric emergency room
Pediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom.
Sponsors
Oulu University Hospital
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomized controlled trial 2:1
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of children with antibiotic prescription at emergency room | Up to 1 day after study entry | Antibiotic consumption at emergency room |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of children receiving macrolide antibiotic at pediatric emergency room | Up to 1 day after study entry | Among all children randomized |
| Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room | Up to 1 day after study entry | Among all children randomized |
| Proportion of children admitted to hospital | Up to 1 day after study entry | Hospital admissions |
| Number of other diagnostic tests than point-of-care test performed at emergency room | Up to 1 day after study entry | Number and cost of diagnostic tests such as blood culture, blood chemistry |
| Proportion of children with readmission to hospital or revisit at emergency room | 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 |
| Proportion of children with outpatient telephone contact within 7 days after discharge from emergency room | 0-7 days | Outpatient telephone contact within 7 days after discharge from emergency room |
| Proportion of children with antibiotics in one week | 0-7 days after study entry | Antimicrobial prescription rate |
| Proportion of children with admission to pediatric intensive care unit or intensive care unit | 0-30 days | Admission to pediatric intensive care unit or intensive care unit |
| Proportion of children who died within one month after study entry | 0-30 days | Mortality |
| Cost in euros per child per visits | 0-7 days after study entry | Visit associated cost (euros) |
| Length of stay at emergency room in minutes | Up to 1 day after study entry | Mean length of visit at emergency room (minutes) |
| Proportion of children receiving correct pathogen directed therapy | 0-7 days after study entry | Antimicrobial use for Mycoplasma pneumoniae, pertussis and influenza |
| Time to initiation of correct pathogen directed therapy | 0-7 days after study entry | Antimicrobials for Mycoplasma pneumoniae, pertussis and influenza (minutes) |
| Number of diagnostic tests per child other than point-of-care test performed within one week | 0-7 days after discharge | Ancillary laboratory testing |
Countries
Finland
Outcome results
None listed