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

NCT ID: NCT03932942

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-06

Study Completion Date

2020-04-13

Brief Summary

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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

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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.

Conditions

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Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial 2:1
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

QIAstat at pediatric emergency room

Intervention Type DIAGNOSTIC_TEST

Pediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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QIAstat at pediatric emergency room

Pediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terhi S Tapiainen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Locations

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Department of Pediatrics, Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 35679047 (View on PubMed)

Other Identifiers

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EETTMK_08_2019

Identifier Type: -

Identifier Source: org_study_id