Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422338
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-10
Brief Title:
A Rapid Triage Test to Improve Risk-stratification of Febrile Children EChiLiBRiST Clinical Trial 1 Outpatients
Sponsor:
Barcelona Institute for Global Health
Organization:
Barcelona Institute for Global Health
Study Overview
Official Title:
A Multi-country Two-arm Open-label Superiority Randomised Controlled Trial to Study the Performance of a Rapid Triage Test Compared to Standard of Care IMCI-based to Guide AdmissionDischarge Decisions During the First Clinical Assessment of Children With Fever
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall aim of the study is to provide evidence that introducing soluble triggering receptor expressed on myeloid cells-1 sTREM-1 evaluation at triaging first clinical assessment in combination with IMCI-based guidelines SoC is a viable strategy to enhance rapid and accurate identification of febrile children at increased risk of life-threatening infections compared to IMCI-based strategies alone SoC and to demonstrate whether this results in enhanced decisions of admissionreferral vs discharge and enhanced overall health outcome of children with acute fever in sub-Saharan Africa
Detailed Description:
This is a multi-country open label two-arm parallel-group superiority individually randomised clinical trial involving 2606 febrile children per country two countries total n5212 The trial will compare the performance of a point-of-care rapid triage test POC-RTT based on sTREM-1 levels ie B-Triage in combination with IMCI-based strategies which are the SoC to appropriately support admissionreferral vs discharge decisions during the first clinical assessment of febrile children aged 2-60 months compared to the standard of care based on IMCI guidelines
Febrile children meeting the study eligibility criteria will be randomly allocated 11 to one of the two triaging approaches arms 1 IMCI-based standard of care SoC or 2 IMCI-enhanced by sTREM-1 levels SoC sTREM-1 POC Blood will be collected from all participants and only those randomised to the intervention arm arm 2 will have sTREM-1 levels determined at the POC using B-Triage device
At baseline all children will undergo two clinical assessments Primary composite endpoint of appropriateness of discharge will be based on the first clinical assessment which is more representative of real-world clinical practice However the ultimate decision on admissionreferral vs discharge will be based on the second clinical assessment which will ensure the safest possible clinical practice in the context of a clinical trial
1 At baseline during the first clinical assessment all participants will be evaluated following the SoC based on IMCI guidelines which will guide management decisions including clinical diagnosis and treatment This IMCI-guideline based evaluation during this first clinical assessment will be conducted by a health worker as per routine clinical practice in the outpatient departments of each study site
1 In the participants randomised to the control arm decision of admissionreferral vs discharge home will be informed by IMCI-based evaluation alone SoC
2 In the participants randomised to the intervention arm decision of admissionreferral vs discharge home will be informed by IMCI-based evaluation enhanced by sTREM-1 levels SoC sTREM-1 POC Clinicians will be instructed to admit for further observation any child with sTREM-1 levels equal or superior to 200 pgmL as these patients are at moderate or high risk of adverse outcomes and death On the other hand children with sTREM-1 levels below 200 pgmL will be eligible for discharge home at the criteria of the clinician considering the signs and symptoms found and based on IMCI guidelines Hence should clinicians in charge deem that any of these children still require admission they will be instructed to continue with the admission regardless of sTREM-1 levels
The study intervention will be implemented during the first clinical assessment and consequently primary composite endpoint of appropriateness of discharge will be based on the decision of admissionreferral vs discharge home during this first clinical assessment which is more representative of routine clinical practice in each study site
2 All randomised participants will be also evaluated by an independent study physician in a second clinical assessment for the implementation of a systematised clinical evaluation IMCI-based to uncover any danger signs or severity criteria potentially missed or misinterpreted during the first assessment This second assessment will also include clinical variables of the clinical scores Paediatric Early Warning Score ED-PEWS Lactate enhanced-quick Sequential Organ Failure Assessment LqSOFA and Logistic Organ Dysfunction Score LODS as well as temperature and oxygen saturation measures Hence study clinicians during this second clinical assessment might be able to uncover more symptoms and signs that are admission criteria due to the tools available in the context of this clinical trial Initially discharged patients from both arms showing a danger sign or other severity criteria during this second assessment will be admitted as well as those from the intervention arm with sTREM-1 high-risk red light and moderate-risk yellow light levels in case that the first clinician might not have adhered to the protocol during the first assessment On the other hand this second assessment will not overturn the decision of the first clinician if admission has been decided in case of sTREM-1 levels below 200 pgmL green light low-risk
This second clinical assessment will guide the ultimate decision on admissionreferral vs discharge in order to ensure the safest possible clinical practice in the context of a clinical trial
Moreover those participants with respiratory symptoms will be eligible for the respiratory tract infection RTI sub-study where digital lung auscultations a mid-turbinate nasal swab and a saliva sample will be collected
Throughout the study all participants will receive treatment as per the routine clinical practice and SoC for each diagnosis at each study site administered by clinical staff routinely working in the participating facilities
All participants will have follow-up evaluations by study clinicians on days 3 and 7 post-enrolment or at any time in-between in case of clinical deterioration according to caregivers evaluation All participants will be also followed-up on day 28 for an interview to follow-up on serious adverse events SAEs as well as to collect information on secondary consultations and hospitalisation or death A follow-up extra visit at day 91 month 3 can be conducted for an interview to ask for hospitalisation or death
Febrile children meeting the study eligibility criteria will be randomly allocated 11 to one of the two triaging approaches arms 1 IMCI-based standard of care SoC or 2 IMCI-enhanced by sTREM-1 levels SoC sTREM-1 POC Blood will be collected from all participants and only those randomised to the intervention arm arm 2 will have sTREM-1 levels determined at the POC using B-Triage device
At baseline all children will undergo two clinical assessments Primary composite endpoint of appropriateness of discharge will be based on the first clinical assessment which is more representative of real-world clinical practice However the ultimate decision on admissionreferral vs discharge will be based on the second clinical assessment which will ensure the safest possible clinical practice in the context of a clinical trial
1 At baseline during the first clinical assessment all participants will be evaluated following the SoC based on IMCI guidelines which will guide management decisions including clinical diagnosis and treatment This IMCI-guideline based evaluation during this first clinical assessment will be conducted by a health worker as per routine clinical practice in the outpatient departments of each study site
1 In the participants randomised to the control arm decision of admissionreferral vs discharge home will be informed by IMCI-based evaluation alone SoC
2 In the participants randomised to the intervention arm decision of admissionreferral vs discharge home will be informed by IMCI-based evaluation enhanced by sTREM-1 levels SoC sTREM-1 POC Clinicians will be instructed to admit for further observation any child with sTREM-1 levels equal or superior to 200 pgmL as these patients are at moderate or high risk of adverse outcomes and death On the other hand children with sTREM-1 levels below 200 pgmL will be eligible for discharge home at the criteria of the clinician considering the signs and symptoms found and based on IMCI guidelines Hence should clinicians in charge deem that any of these children still require admission they will be instructed to continue with the admission regardless of sTREM-1 levels
The study intervention will be implemented during the first clinical assessment and consequently primary composite endpoint of appropriateness of discharge will be based on the decision of admissionreferral vs discharge home during this first clinical assessment which is more representative of routine clinical practice in each study site
2 All randomised participants will be also evaluated by an independent study physician in a second clinical assessment for the implementation of a systematised clinical evaluation IMCI-based to uncover any danger signs or severity criteria potentially missed or misinterpreted during the first assessment This second assessment will also include clinical variables of the clinical scores Paediatric Early Warning Score ED-PEWS Lactate enhanced-quick Sequential Organ Failure Assessment LqSOFA and Logistic Organ Dysfunction Score LODS as well as temperature and oxygen saturation measures Hence study clinicians during this second clinical assessment might be able to uncover more symptoms and signs that are admission criteria due to the tools available in the context of this clinical trial Initially discharged patients from both arms showing a danger sign or other severity criteria during this second assessment will be admitted as well as those from the intervention arm with sTREM-1 high-risk red light and moderate-risk yellow light levels in case that the first clinician might not have adhered to the protocol during the first assessment On the other hand this second assessment will not overturn the decision of the first clinician if admission has been decided in case of sTREM-1 levels below 200 pgmL green light low-risk
This second clinical assessment will guide the ultimate decision on admissionreferral vs discharge in order to ensure the safest possible clinical practice in the context of a clinical trial
Moreover those participants with respiratory symptoms will be eligible for the respiratory tract infection RTI sub-study where digital lung auscultations a mid-turbinate nasal swab and a saliva sample will be collected
Throughout the study all participants will receive treatment as per the routine clinical practice and SoC for each diagnosis at each study site administered by clinical staff routinely working in the participating facilities
All participants will have follow-up evaluations by study clinicians on days 3 and 7 post-enrolment or at any time in-between in case of clinical deterioration according to caregivers evaluation All participants will be also followed-up on day 28 for an interview to follow-up on serious adverse events SAEs as well as to collect information on secondary consultations and hospitalisation or death A follow-up extra visit at day 91 month 3 can be conducted for an interview to ask for hospitalisation or death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None