Clinical trial NCT03932942: Point-of-care Testing of Respiratory Pathogens at Pediatric Emergency Room
Official title: Impact of Multiplex Respiratory Pathogen Testing on Antimicrobial Consumption and Hospital Admissions at Pediatric Emergency Room: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Keywords: Anti-bacterial agents
Emergency room
Respiratory pathogen
Point-of-care testing
Patient admission
Pediatrics
Pediatric emergency medicine
Cost-benefit analysis
Antimicrobial stewardship
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2019-05-01
Enrollment: 1350
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial 2:1
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of children with antibiotic prescription at emergency room
timeFrame: Up to 1 day after study entry
Secondary outcomes:
measure: Proportion of children with antibiotics in one week
timeFrame: 0-7 days after study entry
measure: Proportion of children receiving macrolide antibiotic at pediatric emergency room
timeFrame: Up to 1 day after study entry
measure: Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room
timeFrame: Up to 1 day after study entry
measure: Proportion of children admitted to hospital
timeFrame: Up to 1 day after study entry
measure: Proportion of children admitted to hospital
timeFrame: 0-7 days after study entry
measure: Number of other diagnostic tests than point-of-care test performed at emergency room
timeFrame: Up to 1 day after study entry
measure: Proportion of children with readmission to hospital or revisit at emergency room
timeFrame: 0-7 days after study entry
measure: Proportion of children with outpatient telephone contact within 7 days after discharge from emergency room
timeFrame: 0-7 days
measure: Number of diagnostic tests per child other than point-of-care test performed within one week
timeFrame: 0-7 days after discharge
measure: Proportion of children with admission to pediatric intensive care unit or intensive care unit
timeFrame: 0-30 days
measure: Proportion of children who died within one month after study entry
timeFrame: 0-30 days
measure: Cost in euros per child per visits
timeFrame: 0-7 days after study entry
measure: Length of stay at emergency room in minutes
timeFrame: Up to 1 day after study entry
measure: Proportion of children receiving correct pathogen directed therapy
timeFrame: 0-7 days after study entry
measure: Time to initiation of correct pathogen directed therapy
timeFrame: 0-7 days after study entry
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Department of Pediatrics, Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Terhi S Tapiainen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mattila S, Paalanne N, Honkila M, Pokka T, Tapiainen T. Effect of Point-of-Care Testing for Respiratory Pathogens on Antibiotic Use in Children: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2216162. doi: 10.1001/jamanetworkopen.2022.16162.