Staphylococcus Aureus BacteremiaPET-SABNCT05361135
18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia
A study testing PET/CT in people with Staphylococcus Aureus Bacteremia and Staphylococcus Aureus Septicemia, run by University College, London.
Trial summary
Having bacteria in the blood can be very dangerous. This is called bacteraemia (or bacteremia) or bloodstream infection. It can lead to problems across the whole body, which is what happens in sepsis. Bacteria called Staphylococcus aureus (S. aureus) cause one kind of bacteraemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia, Sepsis Bacterial
- What is being tested?
- PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Jul 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years of age)
- Staphylococcus aureus complex grown from ≥1 blood culture
- Symptoms of S. aureus bloodstream infection
- Admitted to a participating hospital at the time of eligibility assessment . Agrees to PET/CT
Who cannot join
- Contraindication to PET/CT (including pregnancy/breast-feeding)
- PET/CT in the last 7 days or already planned to occur in the next 7 days
- Treating team deems enrolment in the study is not in the best interest of the patient
- Treating team believes that death is imminent and inevitable
- Patient is for end-of-life care and PET/CT is considered not appropriate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Staphylococcus Aureus Bacteraemia (Bacteremia/Bloodstream Infection); an International, Multicentre, Randomised Control Trial
Having bacteria in the blood can be very dangerous. This is called bacteraemia (or bacteremia) or bloodstream infection. It can lead to problems across the whole body, which is what happens in sepsis. Bacteria called Staphylococcus aureus (S. aureus) cause one kind of bacteraemia. Up to a third of people with this condition die within three months, even with antibiotics. One reason for such severe problems is that the bacteria can spread almost anywhere in the body, and hide in places where they are very hard to find. When people with S. aureus bacteraemia come into hospital and have had antibiotics, doctors sometimes cannot tell if they still have an infection source (called a 'focus') hiding in their body. The focus can be like an abscess and may need removing or the pus draining out. A focus might be obvious, if there is pain or swelling, or it might be hidden and deep. If these 'foci' can be found, then doctors can treat them and this helps to cure patients.
To improve survival for patients with these life-threatening infections, it is vital that doctors find the focus of S. aureus bacteraemia as quickly as possible. However, the research team do not know the best way to do this. Most patients with S. aureus bacteraemia have a chest X-ray and a scan of the heart valves. Patients may go to the scanning department lots of times while doctors try to work out where these foci are. This is uncomfortable and takes a lot of time. In about 1 in 5 cases the doctors still cannot find the focus. This is very worrying for patients, their relatives and doctors.
This study has been designed by researchers, doctors and patient advocates. It aims to work out if fewer patients may die when a specific type of scan called a 'PET/CT' is done quickly, because it finds more foci. To do this the team plan to do a clinical trial in patients with S. aureus bacteraemia. Half of the patients will receive the usual tests that patients currently get and the other half will receive an extra scan as soon as possible. The patients will be chosen randomly (like the flip of a coin) to go into one of the 2 groups. A year into the trial, an independent committee will check the results to make sure the extra scan is finding more foci. If this is the case, the trial will carry on. At the end of the study, we will share the results globally. The findings are expected to change the way this dangerous condition is managed, so patients do better.
Read the detailed description
Staphylococcus aureus (S. aureus) bacteraemia/bloodstream infection (SAB) is associated with deep foci in a high proportion of cases, through local or haematogenous spread or seeding. Detecting infectious foci in SAB is a prerequisite to source control, which is critical to improving outcomes. However, in up to 1 in 5 cases no focus can be found, and in others additional foci may be missed. When the foci are not found, this is associated with higher mortality.
Positron emission tomography/computed tomography (usually with 18-fluorodeoxyglucose (FDG), denoted PET/CT) is increasingly available worldwide. The role of PET/CT to rapidly detect deep infectious foci in SAB is becoming clearer with increasing use. The European Medicines Agency licensed FDG for use in PET/CT investigation of bacteraemia based on observational studies. Single-centre observational studies have found PET/CT detected infectious foci in the majority of cases of SAB. A prospective matched cohort study found a suggestion of improved survival with the use of PET/CT, though the rates of solid malignancies and nosocomial infection were higher in the control group. This is a multi-centre randomised controlled trial (RCT) of PET/CT in SAB.
The hypothesis is that PET/CT within 14 days of platform entry to SNAP enables the detection of new foci of infection leading to improved clinical outcomes.
The null hypothesis is that a composite of 90-day all-cause mortality or microbiological relapse or microbiological treatment failure will not be changed by early PET/CT in SAB.
Primary outcome:
A composite of 90-day all-cause mortality or microbiological relapse or microbiological treatment failure 90 days after platform entry.
Secondary outcomes:
The detection of new foci between 0 and 90 days after platform entry. The presence of new foci will be determined by the site investigator and can incorporate clinical, radiological, microbiological and pathological findings.
The presence of new foci will be determined by the site investigator and can incorporate clinical, radiological, microbiological and pathological findings.
All cause mortality at 90 days after platform entry Duration of survival censored at 90 days after platform entry. Length of stay of acute index inpatient hospitalisation for those surviving until hospital discharge (excluding or including HITH/COPAT/OPAT/rehab) truncated at 90 days after platform entry Time to being discharged alive from the total index hospitalisation (excluding or including HITH/COPAT/OPAT/rehab) truncated at 90 days after platform entry.
Microbiological treatment failure defined as positive sterile site culture for S. aureus between 14 and 90 days after platform entry.
Total radiation exposure Patient Eligibility Criteria Inclusion criteria: Adult (≥18 years of age) and consented to the SNAP platform. Agrees to PET/CT.
Exclusion criteria:
Contraindication to PET/CT (including pregnancy/breast-feeding) PET/CT in the last 7 days or already planned to occur in the next 7 days.
- Conditions
- Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia, Sepsis Bacterial, Bloodstream Infection, Staph Sepsis, Staphylococcus Aureus Infection
- Being tested
- PET/CT
- Keywords
- Staphylococcus, Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia, Sepsis, Sepsis Bacterial, Staph Sepsis, Staphylococcus Aureus Infection, Bloodstream Infection, Staphylococcus Aureus Bacteraemia, PET, PET/CT, PET-CT, Positron Emission Tomography, Positron Emission Tomography/Computed Tomography, Diagnostic Imaging
- Medical subject headings
- Sepsis, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDiagnostic test
Also called PET-CT
Enhanced imaging with PET/CT
| Study group | Role | What they receive |
|---|---|---|
| PET/CT | Experimental | Enhanced imaging with PET/CT Receives: Diagnostic Test: PET/CT |
| Routine Imaging | No intervention | Standard of Care Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All cause mortality- Number of participants who are no longer alive at day 90
Measured: 90 days
Secondary outcomes (8)
Total antibiotic days
Total number of days of antibiotic and type (IV or oral delivery) per participant measured at day 90
Measured: 90 days
Source control
Control of infection sites through surgery, drainage and other procedures- Number of participants who receive these procedures and number of participants in whom these procedures are not completed but infectious foci remain
Measured: Time to hospital total discharge [up to 90 days from platform entry]
Number of participants with a change in the planned management strategy
Number of participants with a change in the planned management strategy by date of total hospital discharge (including OPAT)
Measured: Time to hospital total discharge [up to 90 days from platform entry]
Length of Stay
Length of stay of acute index inpatient hospitalisation for participants surviving until hospital discharge
Measured: 90 days
Microbiological failure and relapse
Microbiological treatment failure and relapse defined as positive sterile site culture for S. aureus from a participant
Measured: From 14 to 90 days
Adverse events including total radiation exposure
Total radiation exposure to the participant and serious adverse events
Measured: 90 days
Diagnosis of new infectious foci
Detection of Deep Foci of Infection in the participant (location). The presence of deep foci will be determined by the site investigator and can incorporate clinical, radiological, microbiological and pathological findings.
Measured: Up to 90 days after platform entry
Composite of 90-day all-cause mortality or microbiological relapse or microbiological treatment failure.
Number of participants with a composite of 90-day all-cause mortality or microbiological relapse or microbiological treatment failure. Microbiological relapse is defined as a positive blood culture for S. aureus at least 72 hours after a preceding negative culture. Microbiological treatment failure is defined as a positive sterile-site culture for S. aureus of the same antibiotic resistance as the index isolate at least 21 days after platform entry.
Measured: Up to 90 days after platform entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study startSep 2023 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus BacteremiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University of Melbourne, Menzies School of Health Research, Olivia Newton-John Cancer Research Institute, Alliance Medical, UK, Rambam Health Care Campus
- Responsible party
- Sponsor
- Investigators
- Anna Goodman, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361135
- Sponsor's protocol ID
- PET-SAB
- Acronym
- PET-SAB
- Status last verified
- May 2023
- First submitted
- 29 Apr 2022
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This will be determined with the protocol. It is will be open but would need to protect patient identifiable data.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Staphylococcus Aureus Bacteraemia (Bacteremia/Bloodstream Infection); an International, Multicentre, Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05361135
- Acronym / sponsor ID
- PET-SAB / PET-SAB
- Conditions
- Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia, Sepsis Bacterial, Bloodstream Infection, Staph Sepsis, Staphylococcus Aureus Infection
- Keywords
- Staphylococcus, Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia, Sepsis, Sepsis Bacterial, Staph Sepsis, Staphylococcus Aureus Infection, Bloodstream Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- King's College London, University of Melbourne, Menzies School of Health Research, Olivia Newton-John Cancer Research Institute, Alliance Medical, UK, Rambam Health Care Campus
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 4 May 2022 (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.
Having bacteria in the blood can be very dangerous. This is called bacteraemia (or bacteremia) or bloodstream infection. It can lead to problems across the whole body, which is what happens in sepsis. Bacteria called Staphylococcus aureus (S. aureus) cause one kind of bacteraemia. Up to a third of people with this condition die within three months, even with antibiotics. One reason for such severe problems is that the bacteria can spread almost anywhere in the body, and hide in places where they are very hard to find. When people with S. aureus bacteraemia come into hospital and have had antibiotics, doctors sometimes cannot tell if they still have an infection source (called a 'focus') hiding in their body. The focus can be like an abscess and may need removing or the pus draining out. A focus might be obvious, if there is pain or swelling, or it might be hidden and deep. If these 'foci' can be found, then doctors can treat them and this helps to cure patients.
To improve survival for patients with these life-threatening infections, it is vital that doctors find the focus of S. aureus bacteraemia as quickly as possible. However, the research team do not know the best way to do this. Most patients with S. aureus bacteraemia have a chest X-ray and a scan of the heart valves. Patients may go to the scanning department lots of times while doctors try to work out where these foci are. This is uncomfortable and takes a lot of time. In about 1 in 5 cases the doctors still cannot find the focus. This is very worrying for patients, their relatives and doctors.
This study has been designed by researchers, doctors and patient advocates. It aims to work out if fewer patients may die when a specific type of scan called a 'PET/CT' is done quickly, because it finds more foci. To do this the team plan to do a clinical trial in patients with S. aureus bacteraemia. Half of the patients will receive the usual tests that patients currently get and the other half will receive an extra scan as soon as possible. The patients will be chosen randomly (like the flip of a coin) to go into one of the 2 groups. A year into the trial, an independent committee will check the results to make sure the extra scan is finding more foci. If this is the case, the trial will carry on. At the end of the study, we will share the results globally. The findings are expected to change the way this dangerous condition is managed, so patients do better.
Detailed description
Staphylococcus aureus (S. aureus) bacteraemia/bloodstream infection (SAB) is associated with deep foci in a high proportion of cases, through local or haematogenous spread or seeding. Detecting infectious foci in SAB is a prerequisite to source control, which is critical to improving outcomes. However, in up to 1 in 5 cases no focus can be found, and in others additional foci may be missed. When the foci are not found, this is associated with higher mortality.
Positron emission tomography/computed tomography (usually with 18-fluorodeoxyglucose (FDG), denoted PET/CT) is increasingly available worldwide. The role of PET/CT to rapidly detect deep infectious foci in SAB is becoming clearer with increasing use. The European Medicines Agency licensed FDG for use in PET/CT investigation of bacteraemia based on observational studies. Single-centre observational studies have found PET/CT detected infectious foci in the majority of cases of SAB. A prospective matched cohort study found a suggestion of improved survival with the use of PET/CT, though the rates of solid malignancies and nosocomial infection were higher in the control group. This is a multi-centre randomised controlled trial (RCT) of PET/CT in SAB.
The hypothesis is that PET/CT within 14 days of platform entry to SNAP enables the detection of new foci of infection leading to improved clinical outcomes.
The null hypothesis is that a composite of 90-day all-cause mortality or microbiological relapse or microbiological treatment failure will not be changed by early PET/CT in SAB.
Primary outcome:
A composite of 90-day all-cause mortality or microbiological relapse or microbiological treatment failure 90 days after platform entry.
Secondary outcomes:
The detection of new foci between 0 and 90 days after platform entry. The presence of new foci will be determined by the site investigator and can incorporate clinical, radiological, microbiological and pathological findings.
The presence of new foci will be determined by the site investigator and can incorporate clinical, radiological, microbiological and pathological findings.
All cause mortality at 90 days after platform entry Duration of survival censored at 90 days after platform entry. Length of stay of acute index inpatient hospitalisation for those surviving until hospital discharge (excluding or including HITH/COPAT/OPAT/rehab) truncated at 90 days after platform entry Time to being discharged alive from the total index hospitalisation (excluding or including HITH/COPAT/OPAT/rehab) truncated at 90 days after platform entry.
Microbiological treatment failure defined as positive sterile site culture for S. aureus between 14 and 90 days after platform entry.
Total radiation exposure Patient Eligibility Criteria Inclusion criteria: Adult (≥18 years of age) and consented to the SNAP platform. Agrees to PET/CT.
Exclusion criteria:
Contraindication to PET/CT (including pregnancy/breast-feeding) PET/CT in the last 7 days or already planned to occur in the next 7 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PET/CT | Experimental | Diagnostic Test: PET/CTEnhanced imaging with PET/CT |
| Routine Imaging | No intervention | –Standard of Care Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (≥18 years of age)
- Staphylococcus aureus complex grown from ≥1 blood culture
- Symptoms of S. aureus bloodstream infection
- Admitted to a participating hospital at the time of eligibility assessment . Agrees to PET/CT
Key exclusion criteria (5 listed)
- Contraindication to PET/CT (including pregnancy/breast-feeding)
- PET/CT in the last 7 days or already planned to occur in the next 7 days
- Treating team deems enrolment in the study is not in the best interest of the patient
- Treating team believes that death is imminent and inevitable
- Patient is for end-of-life care and PET/CT is considered not appropriate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CTAlso: PET-CTEnhanced imaging with PET/CT | Diagnostic test | PET/CT |
Primary outcome
Mortality
Time frame: 90 days
All cause mortality- Number of participants who are no longer alive at day 90
8 secondary outcomes
Total antibiotic days
Time frame: 90 days
Source control
Time frame: Time to hospital total discharge [up to 90 days from platform entry]
Number of participants with a change in the planned management strategy
Time frame: Time to hospital total discharge [up to 90 days from platform entry]
Length of Stay
Time frame: 90 days
Microbiological failure and relapse
Time frame: From 14 to 90 days
Adverse events including total radiation exposure
Time frame: 90 days
Diagnosis of new infectious foci
Time frame: Up to 90 days after platform entry
Composite of 90-day all-cause mortality or microbiological relapse or microbiological treatment failure.
Time frame: Up to 90 days after platform entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: Yes. This will be determined with the protocol. It is will be open but would need to protect patient identifiable data.
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RecruitingPhase 4
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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.
Anna Goodman principal investigator
University College, London
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT in people with Staphylococcus Aureus Bacteremia and Staphylococcus Aureus Septicemia, run by University College, London.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Goodman (020 7670 4600, anna.goodman@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2023.