Point-of-care Testing of Respiratory Pathogens at Pediatric Emergency Room
- Conditions
- Respiratory Tract Infections
- Registration Number
- NCT03932942
- Lead Sponsor
- University of Oulu
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1350
- 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
- Need of resuscitation at emergency room
- Need of immediate transfer to pediatric intensive care unit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of children with antibiotic prescription at emergency room Up to 1 day after study entry Antibiotic consumption at emergency room
- Secondary Outcome Measures
Name Time Method Proportion of children receiving correct pathogen directed therapy 0-7 days after study entry Antimicrobial use for Mycoplasma pneumoniae, pertussis and influenza
Proportion of children with antibiotics in one week 0-7 days after study entry Antimicrobial prescription rate
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 0-7 days after study entry Hospital admissions
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
Number of diagnostic tests per child other than point-of-care test performed within one week 0-7 days after discharge Ancillary laboratory testing
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 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)
Time to initiation of correct pathogen directed therapy 0-7 days after study entry Antimicrobials for Mycoplasma pneumoniae, pertussis and influenza (minutes)
Trial Locations
- Locations (1)
Department of Pediatrics, Oulu University Hospital
🇫🇮Oulu, Finland
Department of Pediatrics, Oulu University Hospital🇫🇮Oulu, Finland