Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000052538
Ethics application status
Approved
Date submitted
4/12/2023
Date registered
23/01/2024
Date last updated
23/01/2024
Date data sharing statement initially provided
23/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Sepsis Epidemiology in Paediatric Acute Care International (SENTINEL International) Study
Scientific title
Retrospective cohort study of childhood community acquired sepsis prevalence, severity, and outcomes in low and middle-income countries
Secondary ID [1] 311096 0
None
Universal Trial Number (UTN)
Trial acronym
SENTINEL International
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 332249 0
Condition category
Condition code
Emergency medicine 328964 328964 0 0
Other emergency care
Infection 328965 328965 0 0
Other infectious diseases
Inflammatory and Immune System 328966 328966 0 0
Other inflammatory or immune system disorders
Public Health 328967 328967 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will collect retrospective data over one calendar year from medical records of children with suspected community acquired sepsis. The precise dates over which data will be collected will vary by site, depending on individual site start time (earliest start date will be June 2024). Details regarding hospitalisation for sepsis will be abstracted, such as treatments provided, adverse events, length of stay, and mortality. No patient assessment will occur for study purposes (including physical assessments, tests, or surveys). Only hospital details will be recorded, the duration of the study for individual participants is the duration of hospitalisation.
Intervention code [1] 327544 0
Early Detection / Screening
Intervention code [2] 327545 0
Diagnosis / Prognosis
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337016 0
Sepsis prevalence
Timepoint [1] 337016 0
Over a single calendar year
Primary outcome [2] 337017 0
Community acquired sepsis severity
Timepoint [2] 337017 0
Sepsis severity will be assessed over the duration of index case hospitalisation or 30 days from admission, whichever comes first.
Primary outcome [3] 337018 0
Sepsis outcome.
Timepoint [3] 337018 0
Sepsis outcome will be assessed at hospital discharge or 30 days from admission, whichever comes first.
Secondary outcome [1] 429605 0
Health economic implications of suspected childhood sepsis for hospitals
Timepoint [1] 429605 0
Health economic data will be collected at hospital discharge
Secondary outcome [2] 430366 0
Antimicrobial usage patterns for community acquired sepsis
Timepoint [2] 430366 0
Antimicrobial usage patterns will be assessed at hospital discharge or 30 days from admission, whichever comes first.
Secondary outcome [3] 430367 0
Sepsis microbiology
Timepoint [3] 430367 0
Sepsis microbiology will be assessed at the time of hospital discharge or 30 days from enrolment, whichever comes first.

Eligibility
Key inclusion criteria
Age less than 18 years AND
Admission to hospital AND
Treatment with intravenous (IV)/ intramuscular (IM)/ intraosseous (IO) antibiotics pre-hospital or in ED AND
Circulatory support (fluid bolus or inotropic support) pre-hospital or in ED OR
Admission diagnosis of suspected sepsis, septicaemia or septic shock

Fluid bolus defined as equal to or greater than 5ml/kg or 500mls administered over less than 30 minutes to treat impaired perfusion (not dehydration)
Inotropic support defined as intravenous infusion of inotrope/vasopressor
Minimum age
0 Days
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not initially seen in the Emergency Department (i.e. transferred directly to the ward including ICU)
Patients presenting with trauma
Patients transferred from another hospital if > 24 hours since presentation

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Sample size estimation: sample size will be determined by the number of children presenting who meet inclusion criteria over the study period. We will limit data collection to 1 year.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
2/05/2025
Actual
Sample size
Target
3500
Accrual to date
Final
Recruitment outside Australia
Country [1] 26011 0
Costa Rica
State/province [1] 26011 0
Country [2] 26012 0
India
State/province [2] 26012 0
Country [3] 26013 0
Indonesia
State/province [3] 26013 0
Country [4] 26014 0
Viet Nam
State/province [4] 26014 0
Country [5] 26015 0
Thailand
State/province [5] 26015 0
Country [6] 26016 0
Philippines
State/province [6] 26016 0
Country [7] 26017 0
Sri Lanka
State/province [7] 26017 0

Funding & Sponsors
Funding source category [1] 315355 0
Government body
Name [1] 315355 0
National Health and Medical Research Council
Country [1] 315355 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Murdoch Children's Research Institute
Address
Flemington Road, Parkville, Victoria, 3052
Country
Australia
Secondary sponsor category [1] 317418 0
None
Name [1] 317418 0
Address [1] 317418 0
Country [1] 317418 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314274 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 314274 0
Ethics committee country [1] 314274 0
Australia
Date submitted for ethics approval [1] 314274 0
24/10/2023
Approval date [1] 314274 0
27/11/2023
Ethics approval number [1] 314274 0
HREC/100648/RCHM-2023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131018 0
A/Prof Elliot Long
Address 131018 0
Murdoch Children's Research Institute, Flemington Road, Parkville, Victoria, 3052
Country 131018 0
Australia
Phone 131018 0
+61 425573585
Fax 131018 0
Email 131018 0
[email protected]
Contact person for public queries
Name 131019 0
Elliot Long
Address 131019 0
Murdoch Children's Research Institute, Flemington Road, Parkville, Victoria, 3052
Country 131019 0
Australia
Phone 131019 0
+61 425573585
Fax 131019 0
Email 131019 0
[email protected]
Contact person for scientific queries
Name 131020 0
Elliot Long
Address 131020 0
Murdoch Children's Research Institute, Flemington Road, Parkville, Victoria, 3052
Country 131020 0
Australia
Phone 131020 0
+61 425573585
Fax 131020 0
Email 131020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval for individual participant data has not been obtained


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21117Study protocol  [email protected] 386990-(Uploaded-04-12-2023-13-42-15)-Study-related document.doc



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.