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

University of Oulu

Status: Completed

Conditions: Respiratory Tract Infections

Treatments: Diagnostic Test: QIAstat at pediatric emergency room

Study type: Interventional

Funder types: Other

Identifiers

NCT03932942

EETTMK_08_2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,350 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,350 participants in 2 patient groups

Point-of-care testing of respiratory pathogens on admission

Experimental group

Description:

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.

Treatment:

Diagnostic Test: QIAstat at pediatric emergency room

Routine ED protocol

No Intervention group

Description:

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.