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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,350
Pediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom.
Department of Pediatrics, Oulu University Hospital
Oulu, Finland
Proportion of children with antibiotic prescription at emergency room
Antibiotic consumption at emergency room
Time frame: Up to 1 day after study entry
Proportion of children with antibiotics in one week
Antimicrobial prescription rate
Time frame: 0-7 days after study entry
Proportion of children receiving macrolide antibiotic at pediatric emergency room
Among all children randomized
Time frame: Up to 1 day after study entry
Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room
Among all children randomized
Time frame: Up to 1 day after study entry
Proportion of children admitted to hospital
Hospital admissions
Time frame: Up to 1 day after study entry
Proportion of children admitted to hospital
Hospital admissions
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 0-7 days
Number of diagnostic tests per child other than point-of-care test performed within one week
Ancillary laboratory testing
Time frame: 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
Time frame: 0-30 days
Proportion of children who died within one month after study entry
Mortality
Time frame: 0-30 days
Cost in euros per child per visits
Visit associated cost (euros)
Time frame: 0-7 days after study entry
Length of stay at emergency room in minutes
Mean length of visit at emergency room (minutes)
Time frame: Up to 1 day after study entry
Proportion of children receiving correct pathogen directed therapy
Antimicrobial use for Mycoplasma pneumoniae, pertussis and influenza
Time frame: 0-7 days after study entry
Time to initiation of correct pathogen directed therapy
Antimicrobials for Mycoplasma pneumoniae, pertussis and influenza (minutes)
Time frame: 0-7 days after study entry