Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05259683
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2022-02-10
Brief Title:
Febrile Infant Diagnostic Assessment and Outcome Study
Sponsor:
Queens University Belfast
Organization:
Queens University Belfast
Study Overview
Official Title:
Validating Clinical Decision Aids for the Assessment and Management of Febrile Infants Presenting to Emergency Care in the UK and Ireland
Status:
COMPLETED
Status Verified Date:
2024-02
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:
FIDO
Brief Summary:
Febrile infants under 3 months of age represent a high risk group for invasive bacterial infection IBI and UTI with approximately 10-20 having bacteremia meningitis or urinary tract infection The assessment of febrile infants is challenging and current National Institute for Health and Care Excellence NICE guidance advocates a cautious approach with the majority of infants requiring a septic screen parenteral broad-spectrum antibiotics and admission to hospital Internationally there is significant variation in the approach to febrile infants with European and USA guidance advocating a tailored approach based on clinical features and biomarker testing None of the available clinical decision aids CDA have been validated in a UK and Irish cohort The main objectives of the FIDO study are to report performance accuracy of CDA in a UK United Kingdom and Irish population and describe the aetiology of SBI in young infants
The FIDO study is a prospective observational cohort study of infants under 90 days of age with a measured fever greater than 38 Centrigrade within 24 hours of presentation The study will run for approximately 12 months and recruit a minimum of 1000 participantsSymptoms clinical features and laboratory results will be recorded on an electronic case report form CRF by the attending clinician
The FIDO study is a prospective observational cohort study of infants under 90 days of age with a measured fever greater than 38 Centrigrade within 24 hours of presentation The study will run for approximately 12 months and recruit a minimum of 1000 participantsSymptoms clinical features and laboratory results will be recorded on an electronic case report form CRF by the attending clinician
Detailed Description:
Background
Infants below three months of age are at high risk of invasive bacterial infections IBI and urinary tract infections UTI Recent studies have reported the combined rate of IBI and UTI in the range of 10 - 20 with IBI bacteremia and meningitis account for to up to 3 of the total Unlike older children infants regularly appear well or have non-specific features despite having an IBI or UTI with history and physical examination alone not sufficient to detect all cases Furthermore the clinical differentiation between fever caused by bacteria and viruses is most challenging in the less than three month age group The majority of children still have self-limiting illness in this age group making risk assessment challenging for clinicians
The ideal approach to the assessment and management of febrile infants is not clear as exemplified by the contrasting approaches advocated by the National Institute for Health and Care Excellence NICE The NICE guideline 51 NG51 Sepsis recognition diagnosis and early management advises that all febrile infants under 3 months of age receive parenteral antibiotics immediately whereas NICE guideline 143 NG143 Fever in under 5s assessment and initial management suggests a tailored approach based on clinical assessment and laboratory testing The recently proposed British Society for Antimicrobial Chemotherapy BSAC guidance also supports a tailored approach similar to the NICE guideline NG143 The primary aim of this study is to prospectively validate these CDA
Objectives Primary Objectives
Report the aetiology of IBI in febrile infants under three months in the UK and Ireland
Describe the clinical and laboratory predictors of IBI in febrile infants under three months of age
Report the performance of tailored CDAs to correctly identify a cohort suitable for management without parenteral antibiotics
Report the performance of tailored CDAs to correctly identify a cohort suitable for management without lumbar puncture
Secondary Objectives
Report a cost analysis for different CDAs
Report parentsguardians and clinicians views on how best to communicate different treatment strategies including the risks and benefits of each
Study Design A multicentre observational prospective cohort study in the UK and Ireland conducted via Paediatric Emergency Research in the UK and Ireland PERUKI
Study Population All infants 90 days of age and under with a fever of greater than 38 Centigrade during their time in the Emergency Department ED or Assessment Unit AU or with a history of fever of greater than 38 Centigrade recorded by anyone via any thermometer type within the last 24 hours There are no exclusion criteria but data will be recorded regarding gestational age antenatal complications underlying health conditions and recent admissions to hospital
Setting PERUKI sites across the UK and Ireland
Screening Eligible participants will be screened by appropriately trained clinical staff using the case report form CRF The CRF will be used to record anonymised non-personal data such as baseline demographic data clinical features and initial examination findings
Procedures All eligible participants will be enrolled In all instances routine care will not be interrupted Where possible an additional 1ml of blood will be taken and stored for PCT testing This blood will be collected during routine phlebotomy There will be no additional phlebotomy events beyond those required for routine clinical care Seven days after discharge the CRF will be completed by a trained member of the local study team This will involve reviewing the medical records and a phone call maximum of three attempts to the parentguardian to determine if there had been any subsequent unplanned re-attendances to hospital
Reference Standards The reference standard is the diagnosis of IBI meningitisbacteremia and urinary tract infection excluding contaminants
Urinary Tract Infection UTI will be confirmed by 100000 CFUml of a single organism from a single clean urine clean catch suprapubic aspiration urethral catheter specimen or 100000 Colony Forming Units CFUml of the same single organism from two non-clean urines pads bags cotton wool and the presence of pyuria 5 white blood cells per high powered-field on laboratory microscopy
Meningitis will be confirmed by culture or molecular testing of cerebrospinal fluid CSF The reference standard test will be performed by staff blinded to the clinical data and suspected diagnosis
Bacteremia will be confirmed by culture or molecular testing of blood The reference standard test will be performed by staff blinded to the clinical data and suspected diagnosis
Contaminants include coagulase negative Staphylococcus Propionibacterium acnes Streptococcus viridans or Diphtheroides A list of all suspected contaminants will be provided at the end of the study
Infants below three months of age are at high risk of invasive bacterial infections IBI and urinary tract infections UTI Recent studies have reported the combined rate of IBI and UTI in the range of 10 - 20 with IBI bacteremia and meningitis account for to up to 3 of the total Unlike older children infants regularly appear well or have non-specific features despite having an IBI or UTI with history and physical examination alone not sufficient to detect all cases Furthermore the clinical differentiation between fever caused by bacteria and viruses is most challenging in the less than three month age group The majority of children still have self-limiting illness in this age group making risk assessment challenging for clinicians
The ideal approach to the assessment and management of febrile infants is not clear as exemplified by the contrasting approaches advocated by the National Institute for Health and Care Excellence NICE The NICE guideline 51 NG51 Sepsis recognition diagnosis and early management advises that all febrile infants under 3 months of age receive parenteral antibiotics immediately whereas NICE guideline 143 NG143 Fever in under 5s assessment and initial management suggests a tailored approach based on clinical assessment and laboratory testing The recently proposed British Society for Antimicrobial Chemotherapy BSAC guidance also supports a tailored approach similar to the NICE guideline NG143 The primary aim of this study is to prospectively validate these CDA
Objectives Primary Objectives
Report the aetiology of IBI in febrile infants under three months in the UK and Ireland
Describe the clinical and laboratory predictors of IBI in febrile infants under three months of age
Report the performance of tailored CDAs to correctly identify a cohort suitable for management without parenteral antibiotics
Report the performance of tailored CDAs to correctly identify a cohort suitable for management without lumbar puncture
Secondary Objectives
Report a cost analysis for different CDAs
Report parentsguardians and clinicians views on how best to communicate different treatment strategies including the risks and benefits of each
Study Design A multicentre observational prospective cohort study in the UK and Ireland conducted via Paediatric Emergency Research in the UK and Ireland PERUKI
Study Population All infants 90 days of age and under with a fever of greater than 38 Centigrade during their time in the Emergency Department ED or Assessment Unit AU or with a history of fever of greater than 38 Centigrade recorded by anyone via any thermometer type within the last 24 hours There are no exclusion criteria but data will be recorded regarding gestational age antenatal complications underlying health conditions and recent admissions to hospital
Setting PERUKI sites across the UK and Ireland
Screening Eligible participants will be screened by appropriately trained clinical staff using the case report form CRF The CRF will be used to record anonymised non-personal data such as baseline demographic data clinical features and initial examination findings
Procedures All eligible participants will be enrolled In all instances routine care will not be interrupted Where possible an additional 1ml of blood will be taken and stored for PCT testing This blood will be collected during routine phlebotomy There will be no additional phlebotomy events beyond those required for routine clinical care Seven days after discharge the CRF will be completed by a trained member of the local study team This will involve reviewing the medical records and a phone call maximum of three attempts to the parentguardian to determine if there had been any subsequent unplanned re-attendances to hospital
Reference Standards The reference standard is the diagnosis of IBI meningitisbacteremia and urinary tract infection excluding contaminants
Urinary Tract Infection UTI will be confirmed by 100000 CFUml of a single organism from a single clean urine clean catch suprapubic aspiration urethral catheter specimen or 100000 Colony Forming Units CFUml of the same single organism from two non-clean urines pads bags cotton wool and the presence of pyuria 5 white blood cells per high powered-field on laboratory microscopy
Meningitis will be confirmed by culture or molecular testing of cerebrospinal fluid CSF The reference standard test will be performed by staff blinded to the clinical data and suspected diagnosis
Bacteremia will be confirmed by culture or molecular testing of blood The reference standard test will be performed by staff blinded to the clinical data and suspected diagnosis
Contaminants include coagulase negative Staphylococcus Propionibacterium acnes Streptococcus viridans or Diphtheroides A list of all suspected contaminants will be provided at the end of the study
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