Meningitis, BacterialFIDONCT04196192
Febrile Infants - Diagnostic Assessment and Outcome
An observational study of Meningitis, Bacterial and Bacterial Infections, run by Belfast Health and Social Care Trust at 6 sites in 2 countries.
Trial summary
The purpose of this study is to assess how clinicians apply guidance in the assessment of febrile infants presenting the the Emergency Department. The measurable outcomes are: Primary Objective Report the rates of serious and invasive bacterial infections in febrile infants Secondary Objectives Report on the… Read more about this study
- Who is it for?
- Ages Up to 90 days
- Conditions the study is for
- Meningitis, Bacterial, Bacterial Infections, Urinary Tract Infections
- How many people
- 555 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Mar 2020to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 days
- All sexes
- Child
Study population: Infants aged 0-90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department between the 31/08/2018 and the 01/09/2019.
Who may be able to join
- Any infant aged 0 to 90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United Kingdom5 sites
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT126BE
Bristol Royal Children's Hospital
Bristol
Royal Hospital for Children Glasgow
Glasgow
Leicester Royal Infirmary
Leicester
Royal London Hospital
London
About this study
The purpose of this study is to assess how clinicians apply guidance in the assessment of febrile infants presenting the the Emergency Department. The measurable outcomes are:
Primary Objective Report the rates of serious and invasive bacterial infections in febrile infants
Secondary Objectives Report on the predictive value of different clinical features for predicting bacterial infections.
Report on the value of biomarkers for predicting serious and invasive bacterial infections.
Assess the performance of clinical practice guidelines for the assessment of febrile infants.
Read the detailed description
The assessment of febrile infants is difficult. In the UK and Ireland current guidance advocates that most children under 3 months of age with a fever undergo a full septic screen including lumbar puncture and receive parenteral antibiotics. Approaches in the United States and Europe including the PECARN and StepByStep approach allow for the discharge home of some low risk young infants.
We intend to assess the current approach to febrile infants and compare that to the available clinical practice guidelines. We also intend to determine which clinical and/or laboratory features are most predictive of serious bacterial infection.
- Medical subject headings
- Meningitis, Bacterial, Bacterial Infections, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | All infants aged 0-90 days (inclusive) undergoing routine assessments for fever without source. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive bacterial infection
Invasive Bacterial Infection (non-contaminant) confirmed by culture or molecular diagnostic testing of a sterile site i.e. blood or cerebrospinal fluid (CSF). Staphylococcus epidermidis, Propionibacterium acnes, Streptococcus viridans, or Diphtheroides were considered contaminants.
Measured: seven days
Serious bacterial infections
Urinary tract infections defined as growth of ≥100 000 cfu/mL
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Mar 2020
- Primary completion1 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Meningitis, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol Royal Hospital for Children, University Hospitals, Leicester, Barts & The London NHS Trust, Children's Health Ireland, Royal Hospital for Sick Children, Royal Belfast Hospital for Sick Children
- Responsible party
- Principal investigator, Thomas Waterfield, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196192
- Sponsor's protocol ID
- QIP10/12/19HJ
- Acronym
- FIDO
- Status last verified
- May 2021
- First submitted
- 10 Dec 2019
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised datasets not containing any personal data will be available after publication
Publications
Waterfield T, Foster S, Platt R, Barrett MJ, Durnin S, Maney JA, Roland D, McFetridge L, Mitchell H, Umana E, Lyttle MD; Paediatric Emergency Research in the UK and Ireland (PERUKI). Diagnostic test accuracy of dipstick urinalysis for diagnosing urinary tract infection in febrile infants attending the emergency department. Arch Dis Child. 2022 Dec;107(12):1095-1099. doi: 10.1136/archdischild-2022-324300. Epub 2022 Aug 24.
PubMed 36002228Waterfield T, Lyttle MD, Munday C, Foster S, McNulty M, Platt R, Barrett M, Rogers E, Durnin S, Jameel N, Maney JA, McGinn C, McFetridge L, Mitchell H, Puthucode D, Roland D; Paediatric Emergency Research in the UK and Ireland (PERUKI). Validating clinical practice guidelines for the management of febrile infants presenting to the emergency department in the UK and Ireland. Arch Dis Child. 2022 Apr;107(4):329-334. doi: 10.1136/archdischild-2021-322586. Epub 2021 Sep 16.
PubMed 34531196
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Febrile Infants - Diagnostic Assessment and Outcome
- ClinicalTrials.gov ID
- NCT04196192
- Acronym / sponsor ID
- FIDO / QIP10/12/19HJ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Bristol Royal Hospital for Children, University Hospitals, Leicester, Barts & The London NHS Trust, Children's Health Ireland, Royal Hospital for Sick Children, Royal Belfast Hospital for Sick Children
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess how clinicians apply guidance in the assessment of febrile infants presenting the the Emergency Department. The measurable outcomes are:
Primary Objective Report the rates of serious and invasive bacterial infections in febrile infants
Secondary Objectives Report on the predictive value of different clinical features for predicting bacterial infections.
Report on the value of biomarkers for predicting serious and invasive bacterial infections.
Assess the performance of clinical practice guidelines for the assessment of febrile infants.
Detailed description
The assessment of febrile infants is difficult. In the UK and Ireland current guidance advocates that most children under 3 months of age with a fever undergo a full septic screen including lumbar puncture and receive parenteral antibiotics. Approaches in the United States and Europe including the PECARN and StepByStep approach allow for the discharge home of some low risk young infants.
We intend to assess the current approach to febrile infants and compare that to the available clinical practice guidelines. We also intend to determine which clinical and/or laboratory features are most predictive of serious bacterial infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –All infants aged 0-90 days (inclusive) undergoing routine assessments for fever without source. |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Age groups
- Child
- Study population
- Infants aged 0-90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department between the 31/08/2018 and the 01/09/2019.
Key inclusion criteria (1 listed)
- Any infant aged 0 to 90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Invasive bacterial infection
Time frame: seven days
Invasive Bacterial Infection (non-contaminant) confirmed by culture or molecular diagnostic testing of a sterile site i.e. blood or cerebrospinal fluid (CSF). Staphylococcus epidermidis, Propionibacterium acnes, Streptococcus viridans, or Diphtheroides were considered contaminants.
Serious bacterial infections
Time frame: seven days
Urinary tract infections defined as growth of ≥100 000 cfu/mL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Derived from this study: PubMed 36002228Waterfield T, Foster S, Platt R, Barrett MJ, Durnin S, Maney JA, Roland D, McFetridge L, Mitchell H, Umana E, Lyttle MD; Paediatric Emergency Research in the UK and Ireland (PERUKI). Diagnostic test accuracy of dipstick urinalysis for diagnosing urinary tract infection in febrile infants attending the emergency department. Arch Dis Child. 2022 Dec;107(12):1095-1099. doi: 10.1136/archdischild-2022-324300. Epub 2022 Aug 24.
- Derived from this study: PubMed 34531196Waterfield T, Lyttle MD, Munday C, Foster S, McNulty M, Platt R, Barrett M, Rogers E, Durnin S, Jameel N, Maney JA, McGinn C, McFetridge L, Mitchell H, Puthucode D, Roland D; Paediatric Emergency Research in the UK and Ireland (PERUKI). Validating clinical practice guidelines for the management of febrile infants presenting to the emergency department in the UK and Ireland. Arch Dis Child. 2022 Apr;107(4):329-334. doi: 10.1136/archdischild-2021-322586. Epub 2021 Sep 16.
- Individual participant dataSharing planned: Yes. Anonymised datasets not containing any personal data will be available after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis, Bacterial and Bacterial Infections, run by Belfast Health and Social Care Trust at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive bacterial infection (time frame: seven days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04196192, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.