SepsisNCT03509727
Procalcitonin in Diagnosis of Bacterial Infections in Young Infants
An observational study of Sepsis, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
A diagnostic accuracy study investigating the accuracy of procalcitonin in diagnosing invasive bacterial infections in your infants. Read more about this study
- Who is it for?
- Ages Up to 90 days
- Conditions the study is for
- Sepsis
- How many people
- 126 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2017to 1 Jan 2018
- 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: All young infants presenting to the emergency department with suspected infection are eligible for testing.
Who may be able to join
- Suspected bacterial infection
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point-of-care-testing for Procalcitonin in Diagnosis of Bacterial Infections in Young Infants: a Diagnostic Accuracy Study
A diagnostic accuracy study investigating the accuracy of procalcitonin in diagnosing invasive bacterial infections in your infants.
Read the detailed description
The primary aim of this study was to report on the diagnostic accuracy of procalcitonin in the diagnosis of bacterial infections in young infants. This included invasive bacterial infections; defined as the isolation of a bacterial pathogen in blood or cerebrospinal fluid culture.
We conducted a prospective observational diagnostic accuracy study. Young infants less than 90 days of age presenting to the Royal Belfast Hospital for Sick Children with signs of possible bacterial infection were eligible for inclusion. Eligible infants underwent procalcitonin testing using 0.5ml of whole blood with a BRAHMS assay on the Samsung LABGEO IB10® analyser.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive bacterial infection
Isolation of a bacterial pathogen in blood or cerebrospinal fluid culture
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Aug 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Waterfield, Belfast Health and Social Care Trust
- Investigators
- Michael Shields, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509727
- Sponsor's protocol ID
- PCT
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Waterfield T, Maney JA, Hanna M, Fairley D, Shields MD. Point-of-care testing for procalcitonin in identifying bacterial infections in young infants: a diagnostic accuracy study. BMC Pediatr. 2018 Dec 12;18(1):387. doi: 10.1186/s12887-018-1349-7.
PubMed 30541505
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care-testing for Procalcitonin in Diagnosis of Bacterial Infections in Young Infants: a Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT03509727
- Acronym / sponsor ID
- PCT
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 26 Apr 2018 (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.
A diagnostic accuracy study investigating the accuracy of procalcitonin in diagnosing invasive bacterial infections in your infants.
Detailed description
The primary aim of this study was to report on the diagnostic accuracy of procalcitonin in the diagnosis of bacterial infections in young infants. This included invasive bacterial infections; defined as the isolation of a bacterial pathogen in blood or cerebrospinal fluid culture.
We conducted a prospective observational diagnostic accuracy study. Young infants less than 90 days of age presenting to the Royal Belfast Hospital for Sick Children with signs of possible bacterial infection were eligible for inclusion. Eligible infants underwent procalcitonin testing using 0.5ml of whole blood with a BRAHMS assay on the Samsung LABGEO IB10® analyser.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Age groups
- Child
- Study population
- All young infants presenting to the emergency department with suspected infection are eligible for testing.
Key inclusion criteria (1 listed)
- Suspected bacterial infection
Key exclusion criteria (1 listed)
- None
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: 2 days
Isolation of a bacterial pathogen in blood or cerebrospinal fluid culture
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 26 Apr 2018.
- Derived from this study: PubMed 30541505Waterfield T, Maney JA, Hanna M, Fairley D, Shields MD. Point-of-care testing for procalcitonin in identifying bacterial infections in young infants: a diagnostic accuracy study. BMC Pediatr. 2018 Dec 12;18(1):387. doi: 10.1186/s12887-018-1349-7.
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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.
Michael Shields principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 1 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 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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: 2 days). 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 NCT03509727, which also lists 1 linked publication.
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 26 Apr 2018.