Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580600
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
PREcision Medicine Directed Corticosteroids in Children with PreSchool Wheeze
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Centre Randomised Feasibility Study Using Point-of-care POC Testing for Respiratory Viruses to Direct Oral Corticosteroids Use in Preschool-aged Children with Acute Wheeze
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECISE
Brief Summary:
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
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
Detailed Description:
PRECISE will be a feasibility study conducted as a single-centre prospective randomised open-label study Participants will be screened by the clinical team from attendances to the local Emergency Department ED Participants meeting the study inclusion criteria by age and symptoms will be entered into a screening log If the participant is not recruited the reason will be recorded Participants will be assessed using the inclusion and exclusion criteria described in other sections Eligibility will be flagged by a member of the clinical team and then subsequently confirmed by a member of the research team However the medical care given to and medical decisions made on behalf of participants will be the responsibility of an appropriately qualified treating physician
The research team member will discuss each eligible participant with their treating physician to confirm agreement with study enrolment Parents of eligible children will then be introduced to the research team to provide study information confirm eligibility and obtain informed consent Families will be given time to read the Participant Information Sheets PIS and reflect on their discussion with the researcher who will then offer the opportunity to answer further questions With written informed consent obtained the participant will be enrolled This will require the first nasalnasopharyngeal swab NPS to be collected and tested for RSV and other respiratory viral infections This NPS is for the purposes of the study but results will be made available to the treating clinician and the family Based on the result of Participants NPS they will then be randomised to receive oral corticosteroids OCS or no OCS through an automated process with a 11 ratio Throughout this process clinicians will continue to perform investigations and administer additional standard of care treatment according to local hospital guidance Administration of emergency standard of care treatment will not be delayed pending consent discussions or NPS result
OCS therapy if given will be administered as oral dexamethasone according to local standard of care If the participant vomits within 30 minutes of dexamethasone administration it may be re-administered at the discretion of the treating clinician As there is no blinding to the study participants or clinicians regarding the randomisation allocation the treating clinician may choose to determine the OCS therapy plan at any point after enrolment irrespective of study randomisation based on the patients clinical status
After the initial ED presentation there are two other time points in the study i a review in 2 working days and a phone call at 28 days post enrolment UK BTSSIGN guidance recommends all patients presenting with acute asthma or wheeze should be reviewed following discharge from EDhospital within two working days This is not routinely offered locally however for the purposes of the study participants will be offered a review with a clinical member of the research team and a repeat nasal swab event will take place A member of the research team will call parents on day 28 to complete each childs research record
Additionally participants may consent to an optional finger prick blood testing at enrolment to elicit their blood eosinophil count using a Point of care POC white cell differential device As with the NPS result the family and clinicians will be made aware of the result
Finally parents of participants in the PRECISE study will be invited to take part in semi-structured interviews after the day 28 call for further feasability and acceptability analysis
The research team member will discuss each eligible participant with their treating physician to confirm agreement with study enrolment Parents of eligible children will then be introduced to the research team to provide study information confirm eligibility and obtain informed consent Families will be given time to read the Participant Information Sheets PIS and reflect on their discussion with the researcher who will then offer the opportunity to answer further questions With written informed consent obtained the participant will be enrolled This will require the first nasalnasopharyngeal swab NPS to be collected and tested for RSV and other respiratory viral infections This NPS is for the purposes of the study but results will be made available to the treating clinician and the family Based on the result of Participants NPS they will then be randomised to receive oral corticosteroids OCS or no OCS through an automated process with a 11 ratio Throughout this process clinicians will continue to perform investigations and administer additional standard of care treatment according to local hospital guidance Administration of emergency standard of care treatment will not be delayed pending consent discussions or NPS result
OCS therapy if given will be administered as oral dexamethasone according to local standard of care If the participant vomits within 30 minutes of dexamethasone administration it may be re-administered at the discretion of the treating clinician As there is no blinding to the study participants or clinicians regarding the randomisation allocation the treating clinician may choose to determine the OCS therapy plan at any point after enrolment irrespective of study randomisation based on the patients clinical status
After the initial ED presentation there are two other time points in the study i a review in 2 working days and a phone call at 28 days post enrolment UK BTSSIGN guidance recommends all patients presenting with acute asthma or wheeze should be reviewed following discharge from EDhospital within two working days This is not routinely offered locally however for the purposes of the study participants will be offered a review with a clinical member of the research team and a repeat nasal swab event will take place A member of the research team will call parents on day 28 to complete each childs research record
Additionally participants may consent to an optional finger prick blood testing at enrolment to elicit their blood eosinophil count using a Point of care POC white cell differential device As with the NPS result the family and clinicians will be made aware of the result
Finally parents of participants in the PRECISE study will be invited to take part in semi-structured interviews after the day 28 call for further feasability and acceptability analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None