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

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ClinicalTrials.gov Identifier: NCT03932942
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1668 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
Estimated Primary Completion Date : May 2, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


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.



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 energency 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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932942


Contacts
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Contact: Terhi S Tapiainen, MD,PhD +358407054677 terhi.tapiainen@oulu.fi
Contact: Suvi T Mattila, MD +35883155811 suvi.mattila@ppshp.fi

Locations
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Finland
Department of Pediatrics, Oulu University Hospital Recruiting
Oulu, Finland, 90014
Contact: Terhi Tapiainen, MD, PhD    +358-8-315 5185    terhi.tapiainen@oulu.fi   
Principal Investigator: Terhi Tapiainen, MD, PhD         
Sub-Investigator: Suvi Mattila, MD         
Sub-Investigator: Niko Paalanne, MD, PhD         
Sub-Investigator: Minna Honkila, MD, PhD         
Sub-Investigator: Tytti Pokka, MSc         
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Investigators
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Principal Investigator: Terhi S Tapiainen, MD,PhD Oulu University Hospital

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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT03932942     History of Changes
Other Study ID Numbers: EETTMK_08_2019
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
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

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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:
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Respiratory Tract Infections
Emergencies
Disease Attributes
Pathologic Processes
Infection
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents