Respiratory Tract InfectionsHevi-RCTNCT03932942
Point-of-care Testing of Respiratory Pathogens at Pediatric Emergency Room
A study testing QIAstat at pediatric emergency room in people with Respiratory Tract Infections, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- QIAstat at pediatric emergency room
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 1 siteFinland
- Study dates
- 6 May 2019to 13 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Need of resuscitation at emergency room
- Need of immediate transfer to pediatric intensive care unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Multiplex Respiratory Pathogen Testing on Antimicrobial Consumption and Hospital Admissions at Pediatric Emergency Room: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Respiratory Tract Infections
- Being tested
- QIAstat at pediatric emergency room
- Keywords
- Anti-bacterial agents, Emergency room, Respiratory pathogen, Point-of-care testing, Patient admission, Pediatrics, Pediatric emergency medicine, Cost-benefit analysis, Antimicrobial stewardship
- Medical subject headings
- Respiratory Tract Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QIAstat at pediatric emergency roomDiagnostic test
Pediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with antibiotic prescription at emergency room
Antibiotic consumption at emergency room
Measured: Up to 1 day after study entry
Secondary outcomes (15)
Proportion of children with antibiotics in one week
Antimicrobial prescription rate
Measured: 0-7 days after study entry
Proportion of children receiving macrolide antibiotic at pediatric emergency room
Among all children randomized
Measured: Up to 1 day after study entry
Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room
Among all children randomized
Measured: Up to 1 day after study entry
Proportion of children admitted to hospital
Hospital admissions
Measured: Up to 1 day after study entry
Proportion of children admitted to hospital
Hospital admissions
Measured: 0-7 days after study entry
Number of other diagnostic tests than point-of-care test performed at emergency room
Number and cost of diagnostic tests such as blood culture, blood chemistry
Measured: Up to 1 day after study entry
Proportion of children with readmission to hospital or revisit at emergency room
Proportion of children with hospital readmission or emergency room revisit within 7 days after discharge from ED or hospital
Measured: 0-7 days after study entry
Proportion of children with outpatient telephone contact within 7 days after discharge from emergency room
Outpatient telephone contact within 7 days after discharge from emergency room
Measured: 0-7 days
Number of diagnostic tests per child other than point-of-care test performed within one week
Ancillary laboratory testing
Measured: 0-7 days after discharge
Proportion of children with admission to pediatric intensive care unit or intensive care unit
Admission to pediatric intensive care unit or intensive care unit
Measured: 0-30 days
Proportion of children who died within one month after study entry
Mortality
Measured: 0-30 days
Cost in euros per child per visits
Visit associated cost (euros)
Measured: 0-7 days after study entry
Length of stay at emergency room in minutes
Mean length of visit at emergency room (minutes)
Measured: Up to 1 day after study entry
Proportion of children receiving correct pathogen directed therapy
Antimicrobial use for Mycoplasma pneumoniae, pertussis and influenza
Measured: 0-7 days after study entry
Time to initiation of correct pathogen directed therapy
Antimicrobials for Mycoplasma pneumoniae, pertussis and influenza (minutes)
Measured: 0-7 days after study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start6 May 2019
- Primary completion20 Mar 2020
- Study completion13 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial 2:1
- Masking
- None (open label)
- Enrolment
- 1,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Sponsor
- Investigators
- Terhi S Tapiainen, MD,PhD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932942
- Sponsor's protocol ID
- EETTMK_08_2019
- Acronym
- Hevi-RCT
- Status last verified
- Nov 2020
- First submitted
- 23 Apr 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be shared according to the practice in place at the time of the study completion.
Publications
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.
PubMed 35679047
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multiplex Respiratory Pathogen Testing on Antimicrobial Consumption and Hospital Admissions at Pediatric Emergency Room: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03932942
- Acronym / sponsor ID
- Hevi-RCT / EETTMK_08_2019
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,350 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- 6 May 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial 2:1
| Arm | Type | Receives |
|---|---|---|
| Point-of-care testing of respiratory pathogens on admission | Experimental | Diagnostic Test: QIAstat at pediatric emergency roomPoint-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. |
| 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Need of resuscitation at emergency room
- Need of immediate transfer to pediatric intensive care unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QIAstat at pediatric emergency roomPediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom. | Diagnostic test | Point-of-care testing of respiratory pathogens on admission |
Primary outcome
Proportion of children with antibiotic prescription at emergency room
Time frame: Up to 1 day after study entry
Antibiotic consumption at emergency room
15 secondary outcomes
Proportion of children with antibiotics in one week
Time frame: 0-7 days after study entry
Proportion of children receiving macrolide antibiotic at pediatric emergency room
Time frame: Up to 1 day after study entry
Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room
Time frame: Up to 1 day after study entry
Proportion of children admitted to hospital
Time frame: Up to 1 day after study entry
Proportion of children admitted to hospital
Time frame: 0-7 days after study entry
Number of other diagnostic tests than point-of-care test performed at emergency room
Time frame: Up to 1 day after study entry
Proportion of children with readmission to hospital or revisit at emergency room
Time frame: 0-7 days after study entry
Proportion of children with outpatient telephone contact within 7 days after discharge from emergency room
Time frame: 0-7 days
Number of diagnostic tests per child other than point-of-care test performed within one week
Time frame: 0-7 days after discharge
Proportion of children with admission to pediatric intensive care unit or intensive care unit
Time frame: 0-30 days
Proportion of children who died within one month after study entry
Time frame: 0-30 days
Cost in euros per child per visits
Time frame: 0-7 days after study entry
Length of stay at emergency room in minutes
Time frame: Up to 1 day after study entry
Proportion of children receiving correct pathogen directed therapy
Time frame: 0-7 days after study entry
Time to initiation of correct pathogen directed therapy
Time frame: 0-7 days after study entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 35679047Mattila 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.
- Individual participant dataSharing planned: Yes. Anonymized data will be shared according to the practice in place at the time of the study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terhi S Tapiainen, MD,PhD principal investigator
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QIAstat at pediatric emergency room in people with Respiratory Tract Infections, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children with antibiotic prescription at emergency room (time frame: Up to 1 day after study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03932942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.