Point-of-care Testing of Respiratory Pathogens at Pediatric Emergency Room (Hevi-RCT)

• ClinicalTrials.gov Identifier: NCT03932942
• Recruitment Status: Completed
• First Posted: May 1, 2019
• Last Update Posted: November 4, 2020
• Sponsor: University of Oulu
• Collaborator: Oulu University Hospital
• Information provided by (Responsible Party): University of Oulu

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Tract Infections	Diagnostic Test: QIAstat at pediatric emergency room	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial 2:1
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Impact of Multiplex Respiratory Pathogen Testing on Antimicrobial Consumption and Hospital Admissions at Pediatric Emergency Room: A Randomized Controlled Trial
• Actual Study Start Date: May 6, 2019
• Actual Primary Completion Date: March 20, 2020
• Actual Study Completion Date: April 13, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Point-of-care testing of respiratory pathogens on admission; Point-of-care testing of respiratory pathogens on admission. The subjects will receive the point-of-care testing of respiratory pathogens at pediatric emergency room. The results are ready within 1 one hour.	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.
No Intervention: Routine ED protocol; Diagnostic tests for respiratory pathogens will be obtained according to clinical judgement and tested on microbiological laboratory. The results are ready on the next office day.

Outcome Measures

Primary Outcome Measures :

1. Proportion of children with antibiotic prescription at emergency room [ Time Frame: Up to 1 day after study entry ]
   Antibiotic consumption at emergency room

Secondary Outcome Measures :

1. Proportion of children with antibiotics in one week [ Time Frame: 0-7 days after study entry ]
   Antimicrobial prescription rate
2. Proportion of children receiving macrolide antibiotic at pediatric emergency room [ Time Frame: Up to 1 day after study entry ]
   Among all children randomized
3. Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room [ Time Frame: Up to 1 day after study entry ]
   Among all children randomized
4. Proportion of children admitted to hospital [ Time Frame: Up to 1 day after study entry ]
   Hospital admissions
5. Proportion of children admitted to hospital [ Time Frame: 0-7 days after study entry ]
   Hospital admissions
6. Number of other diagnostic tests than point-of-care test performed at emergency room [ Time Frame: Up to 1 day after study entry ]
   Number and cost of diagnostic tests such as blood culture, blood chemistry
7. Proportion of children with readmission to hospital or revisit at emergency room [ Time Frame: 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
8. Proportion of children with outpatient telephone contact within 7 days after discharge from emergency room [ Time Frame: 0-7 days ]
   Outpatient telephone contact within 7 days after discharge from emergency room
9. Number of diagnostic tests per child other than point-of-care test performed within one week [ Time Frame: 0-7 days after discharge ]
   Ancillary laboratory testing
10. Proportion of children with admission to pediatric intensive care unit or intensive care unit [ Time Frame: 0-30 days ]
    Admission to pediatric intensive care unit or intensive care unit
11. Proportion of children who died within one month after study entry [ Time Frame: 0-30 days ]
    Mortality
12. Cost in euros per child per visits [ Time Frame: 0-7 days after study entry ]
    Visit associated cost (euros)
13. Length of stay at emergency room in minutes [ Time Frame: Up to 1 day after study entry ]
    Mean length of visit at emergency room (minutes)
14. Proportion of children receiving correct pathogen directed therapy [ Time Frame: 0-7 days after study entry ]
    Antimicrobial use for Mycoplasma pneumoniae, pertussis and influenza
15. Time to initiation of correct pathogen directed therapy [ Time Frame: 0-7 days after study entry ]
    Antimicrobials for Mycoplasma pneumoniae, pertussis and influenza (minutes)

Eligibility Criteria

• Ages Eligible for Study: up to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Finland

Department of Pediatrics, Oulu University Hospital

Oulu, Finland, 90014

Sponsors and Collaborators

University of Oulu

Oulu University Hospital

Investigators

• Principal Investigator: Terhi S Tapiainen, MD,PhD; Oulu University Hospital

More Information

• Responsible Party: University of Oulu
• ClinicalTrials.gov Identifier: NCT03932942
• Other Study ID Numbers: EETTMK_08_2019
• First Posted: May 1, 2019
• Last Update Posted: November 4, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Anonymized data will be shared according to the practice in place at the time of the study completion.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: At the study completion or at submission
• Access Criteria: For reviewers and editors before publishing and after publishing for the whole research community

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Oulu:

Anti-bacterial agents; Emergency room; Respiratory pathogen; Point-of-care testing; Patient admission; Pediatrics; Pediatric emergency medicine; Cost-benefit analysis; Antimicrobial stewardship

Additional relevant MeSH terms:

Respiratory Tract Infections; Emergencies; Disease Attributes; Pathologic Processes; Infections; Respiratory Tract Diseases