Impact of 18 FDG PET/CT on the Management of Patients With Staphylococcus Aureus Bloodstream Infection

NCT03419221 | Completed DMC

• 1 other identifier: UF 9788
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

Brief Summary

S. aureus bloodstream infection (SAB) is a severe disease associated with a 30% case-fatality rate at 12 weeks. Severity of this disease is related to the high prevalence of staphylococcal Deep Foci of Infection (SA-DFI), which require prolonged duration of antimicrobial therapy and specific treatment. Timely diagnosis and management of SA-DFI is associated with an improvement of prognosis during SAB. 18 FDG PET/CT (PET/CT) is a useful tool in the diagnosis of infectious foci during bacterial infections. An ecological study performed in the Netherlands has shown that use of PET/CT in patients with Gram positive cocci bloodstream infection was associated with an increase of detection of DFI and a decrease of recurrences and mortality compared to historical controls. The investigators hypothesize that SAB poor prognosis is in part related to the lack of diagnosis of all infectious foci and consequently to a suboptimal treatment.

Conditions

Staphylococcus Aureus

Keywords

Staphylococcus aureus; bloodstream infection; deep foci of infection; 18 FDG PET/CT; antibiotics

Outcome Measures

Primary Outcomes (1)

• Presence of at least one DFI following the drawing of the first blood positive culture.

  SA-DFI will be defined as the presence of at least one of the following criteria adapted form the criteria proposed by EMA for evaluation of antibiotics (EMA): * Deep collection without any other explanation than S. aureus infection * Osteomyelitis or arthritis without any other explanation than S. aureus infection; in case of presence of material (osteosynthesis or prosthetic joint) the presence of clinical symptoms or bacteriological confirmation will be required because the specificity of imaging including PET/CT is low * Isolation of S. aureus in a sterile site other than blood, urine or catheter (eg: pleura, cerebrospinal fluid, bone, synovial fluid, muscle…)

  day 14

Secondary Outcomes (14)

• PET/CT Evaluation :Frequency of SA-DFI

  day 14

• PET/CT Evaluation :Time to detection

  day 14

• Duration of Antibiotic treatment

  3 months

• Duration of Antibiotic treatment

  6 months

• frequency of Diagnostic procedures

  3 months

Study Arms (2)

A: Patients with PET/CT performs at day 14 after the drawing

ACTIVE COMPARATOR

Arm A: Patients with PET/CT performs at day 14 after the drawing of the first blood culture

Procedure: PET/CT Positron emission tomography (PET) using small radiotracers, a special camera and a computer to evaluate organ and tissue functions

B : Patients' routine care with performance of explorations

PLACEBO COMPARATOR

Arm B : Patients' routine care with performance of explorations based on anamnesis and clinical symptoms

Other: Patients' routine care with performance of explorations based on anamnesis and clinical symptoms

Interventions

PET/CT Positron emission tomography (PET) using small radiotracers, a special camera and a computer to evaluate organ and tissue functions PROCEDURE

Open-label randomized controlled superiority trial in patients with SAB without infective endocarditis at the time of inclusion comparing whole-body PET/CT in arm A and routine care with performance of imaging studies according to anamnesis and clinical symptoms in arm B. To demonstrate that PET/CT is associated with a 20% higher frequency of detection of DFI during SAB, the inclusion of 145 patients in each arm is required. Randomization will be stratified on centre and SAB setting of acquisition (healthcare vs community).

A: Patients with PET/CT performs at day 14 after the drawing

Patients' routine care with performance of explorations based on anamnesis and clinical symptoms OTHER

Patients' routine care with performance of explorations based on anamnesis and clinical symptoms

B : Patients' routine care with performance of explorations

Eligibility Criteria

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

You may qualify if:

• \- Aged over 18 years
• Signed informed consent form
• Subjects must be able to attend all scheduled visits and to comply with all trial procedures
• Subjects must be covered by public health insurance
• Hospitalized in one of the 10 participating centres
• At least one peripheral blood culture isolating S. aureus
• Absence of diagnosis of IE according to at least a transthoracic cardiac echography; cardiac echography will be performed via transesophageal procedure if the VIRSTA score is 3 or higher (see Appendix) or if transthoracic echography is not normal.

You may not qualify if:

• \- Any reason that may compromise compliance with the visit plan
• Planned longer stay outside the region that prevents compliance with the visit plan
• Deprived of liberty subjects (by judicial or administrative decision)
• Adult under guardianshipCatheter-related SAB with resolution of symptoms of infection within 24 hours of ablation of catheter
• Pregnancy or lactation
• Isolation of S. aureus only in blood cultures drawn from a catheter or another implanted device
• Catheter-related SAB with resolution of symptoms of infection within 24 hours of ablation of catheter
• Uncontrolled septic shock and other instability contra-indicating the performance of PET/CT
• Previous performance of PET/CT for the present episode of SAB
• Indication to PET/CT for another reason (eg. neoplasm, infection of vascular graft…)
• Contra-indication to PET/CT
• Contraindication to Fluorodeoxyglucose : hypersensitivity to the active substance or to any of the excipients
• Participation to another study unless specific authorization of the steering committee

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Chu Gui de Chauliac

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Staphylococcal Infections; Sepsis

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

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

Study Officials

• Vincent LE MOING, Professor

  Infectious Diseases department of CHU-Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: February 1, 2018
• Study Start: January 29, 2018
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

FR (1)