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

Respiratory Tract Infections Clinical Trial

— Hevi-RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03932942
• Other study ID #: EETTMK_08_2019
• Status: Completed
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: April 13, 2020

Study information

• Verified date: November 2020
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1350
• Est. completion date: April 13, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Respiratory Tract Infections

Intervention

Diagnostic Test:
• QIAstat at pediatric emergency room
Pediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom.

Locations

Country	Name	City	State
Finland	Department of Pediatrics, Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children with antibiotic prescription at emergency room	Antibiotic consumption at emergency room	Up to 1 day after study entry
Secondary	Proportion of children with antibiotics in one week	Antimicrobial prescription rate	0-7 days after study entry
Secondary	Proportion of children receiving macrolide antibiotic at pediatric emergency room	Among all children randomized	Up to 1 day after study entry
Secondary	Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room	Among all children randomized	Up to 1 day after study entry
Secondary	Proportion of children admitted to hospital	Hospital admissions	Up to 1 day after study entry
Secondary	Proportion of children admitted to hospital	Hospital admissions	0-7 days after study entry
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of diagnostic tests per child other than point-of-care test performed within one week	Ancillary laboratory testing	0-7 days after discharge
Secondary	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
Secondary	Proportion of children who died within one month after study entry	Mortality	0-30 days
Secondary	Cost in euros per child per visits	Visit associated cost (euros)	0-7 days after study entry
Secondary	Length of stay at emergency room in minutes	Mean length of visit at emergency room (minutes)	Up to 1 day after study entry
Secondary	Proportion of children receiving correct pathogen directed therapy	Antimicrobial use for Mycoplasma pneumoniae, pertussis and influenza	0-7 days after study entry
Secondary	Time to initiation of correct pathogen directed therapy	Antimicrobials for Mycoplasma pneumoniae, pertussis and influenza (minutes)	0-7 days after study entry