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

NCT03932942 | Completed

• 1 other identifier: EETTMK_08_2019
• Study Type: interventional
• Target: 1,350
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of children with antibiotic prescription at emergency room

  Antibiotic consumption at emergency room

  Up to 1 day after study entry

Secondary Outcomes (15)

• Proportion of children with antibiotics in one week

  0-7 days after study entry

• Proportion of children receiving macrolide antibiotic at pediatric emergency room

  Up to 1 day after study entry

• Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room

  Up to 1 day after study entry

• Proportion of children admitted to hospital

  Up to 1 day after study entry

• Proportion of children admitted to hospital

  0-7 days after study entry

Study Arms (2)

Point-of-care testing of respiratory pathogens on admission

EXPERIMENTAL

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

Routine ED protocol

NO INTERVENTION

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.

Interventions

QIAstat at pediatric emergency room DIAGNOSTIC_TEST

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

Point-of-care testing of respiratory pathogens on admission

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Need of resuscitation at emergency room
• Need of immediate transfer to pediatric intensive care unit

Sponsors & Collaborators

• University of Oulu: lead
• Oulu University Hospital: collaborator

Study Sites (1)

Department of Pediatrics, Oulu University Hospital

Oulu, 90014, Finland

Location

Related Publications (1)

• 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.

  PMID: 35679047 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Emergencies

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Terhi S Tapiainen, MD,PhD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial 2:1

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 1, 2019
• Study Start: May 6, 2019
• Primary Completion: March 20, 2020
• Study Completion: April 13, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

FI (1)