18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia

NCT05361135 | Not Yet Recruiting DMC

• 1 other identifier: PET-SAB
• Study Type: interventional
• Target: 820
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Septicemia; Sepsis Bacterial; Bloodstream Infection; Staph Sepsis; Staphylococcus Aureus Infection; Sepsis

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

Outcome Measures

Primary Outcomes (1)

• Mortality

  All cause mortality- Number of participants who are no longer alive at day 90

  90 days

Secondary Outcomes (8)

• Total antibiotic days

  90 days

• Source control

  Time to hospital total discharge [up to 90 days from platform entry]

• Number of participants with a change in the planned management strategy

  Time to hospital total discharge [up to 90 days from platform entry]

• Length of Stay

  90 days

• Microbiological failure and relapse

  From 14 to 90 days

Study Arms (2)

PET/CT

EXPERIMENTAL

Enhanced imaging with PET/CT

Diagnostic Test: PET/CT

Routine Imaging

NO INTERVENTION

Standard of Care Imaging

Interventions

PET/CT DIAGNOSTIC_TEST

Enhanced imaging with PET/CT

Also known as: PET-CT

PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• King's College London: collaborator
• University of Melbourne: collaborator
• Menzies School of Health Research: collaborator
• Olivia Newton-John Cancer Research Institute: collaborator
• Alliance Medical, UK: collaborator
• Rambam Health Care Campus: collaborator

MeSH Terms

Conditions

Sepsis; Staphylococcal Infections

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Anna Goodman

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Goodman

CONTACT

020 7670 4600; anna.goodman@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: September 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: To be determined
• Access Criteria: Open access Study Protocol