PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze
ConditionWheezing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-60
SponsorQueen's University, Belfast
About this trial
Young children frequently attend the emergency department (ED) with wheeze which is usually triggered by a virus infection, such as the common cold. Wheeze can be treated with inhaled medications and sometimes oral steroid medicines are also given to reduce swelling within the lungs. Unfortunately, oral steroids can have side effects. Despite lots of research there is no clear evidence that oral steroids work in young children with a wheeze attack. It is likely that some children get better quicker with oral steroids but deciding who to treat is difficult. This results in differences in care with some children receiving unnecessary oral steroids and others not receiving them when they could benefit.
The investigators hypothesise that in a subgroup of children with mild-to-moderate acute wheeze attacks, the viral trigger can predict their response to steroid medications. Previously, respiratory virus testing was too slow to be used to inform treatments in the ED. Now, point-of-care (POC) viral tests can provide results within 30 minutes. There is a research gap regarding the role of these tests in determining steroid responsiveness and outcomes in children presenting with acute wheeze in the pre-school population.
In order to address the hypothesis in a future definitive trial, the feasibility of using (POC) viral tests to randomise steroid treatments for children in a clinical study in the ED setting must be ascertained. The PRECISE Study will therefore be a single centre randomised, feasibility study enrolling approximately 60 pre-school aged children to inform a future definitive multi-centre Randomised Controlled Trial.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
24-60 months (infants from 24 months +0 days to 60 months + 0 days inclusive)
Clinical diagnosis of acute wheeze
Clinical uncertainty regarding the benefit of OCS as part of patient's standard care
Disqualifiers
Signs and symptoms of severe or life-threatening wheeze
Patients presenting with wheeze suspicious for a non - respiratory cause
Clinical evidence of shock or bacterial sepsis
Past history of severe or life-threatening asthma or history of previous PICU admission with acute wheeze
Trial design
Design model
Single group
Treatments tested in this trial
Point of care respiratory virus testing
Diagnostic testPatients to be randomised to receive OCS based on the the result of the RSV results within their respiratory virus test. This test will be performed as a point of care (POC) test in ED. This intervention will stratify the randomisation in a 1:1 ratio, to receive OCS or not. NB) Whilst the respiratory pathogen test is not routine care to determine the OCS prescription, it is frequently used within this setting. Additionally both the receipt (or not the receipt) of OCS is within standard care pathway. For the purpose of the trial OCS = Dexamethasone, which is delivered as oral suspension 300mcg/kg as per standard practice within the local Trust.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: OCSActive comparator 1 intervention
Group B: No OCSNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment
Reporting the proportion of eligible patients that are enrolled in the PRECISE Study following screening Reporting all reasons for not screening enrolling any eligible patients.
Time frame
Screening Log completed through study completion, (estimated < 1 year)2
Adherance
Reporting the proportion of randomised patients remaining in allocated treatment arm. I.e. how many patients randomised to NOT recieve OCS have received them within 28 days of enrolment.
Time frame
measured at visit 2 and at 28 days post enrolment per patient. Throughout study completion, (estimated < 1 year)3
Timeliness
The time (minutes) for i) triage to clinician decision regarding eligibility to enrolment ii) screening until availability of POC test results iii) screening to documented time of randomisation iv) screening to documented time of OCS administration (if applicable)
Time frame
Timeliness measured on CRFs throughout study completion, (estimated < 1 year)4
Acceptability
Description of parent/guardian feedback on how acceptable the process of being enrolled and randomised in the study was. This includes a description of perceived barriers to future definitive trial collected from families.
Time frame
Collected at 2 and 28 days post enrolment per patient. Data collected through study completion, (estimated < 1 year))Secondary outcomes
1
viral aetiology
To describe viral aetiology of preschool wheeze in included cohort. I.e. the proportions of patients with positive respiratory viral tests for RSV and/or other respiratory virus/ or no virus detected. This includes a description of the CT - values associated with positive respiratory viral test results.
Time frame
Through study completion, (estimated < 1 year)2
Concordance of test results
The proportions of patients with discordant respiratory viral tests over consecutive visits.
Time frame
Between enrolment and the second visit. (Throughout study completion, (estimated < 1 year))3
Acceptability of tests to formulate plan
To assess parent/guardian acceptability of using a viral POC test in ED to formulate a management plan for pre-school wheeze (using a mixed methods approach).
Time frame
Data collected within one month of enrolment. Throughout study completion, (estimated < 1 year)4
Acceptability of tests to be repeated in study
To assess the feasibility of obtaining second nasal/nasopharyngeal (NP) swab and achieving follow up at specified time points
Time frame
Data collected within one month of enrolment. Throughout study completion, (estimated < 1 year)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Queen's University, Belfast
Lead sponsor
Asthma UK
Collaborator
Pediatric Emergency Research in the UK and Ireland (PERUKI)
Collaborator
Source ClinicalTrials.gov