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New treatment option for Staphylococcus Aureus Bacteremia
Official title Staphylococcus Aureus Network Adaptive Platform Trial
ClinicalTrials.gov ID: NCT05137119
What this study is testing
What is Cefazolin?
Cefazolin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for staphylococcus aureus bacteremia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is an International Multi-Centered Randomised Adaptive Platform Clinical Trial to evaluate a range of interventions to reduce mortality for patients with Staphylococcus Aureus bacteraemia (SAB).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- PLATFORM Patients must fulfil all of the following criteria to be eligible to enter the SNAP trial:
- Staphylococcus aureus complex grown from ≥1 blood culture
- Admitted to a participating hospital at the time of eligibility assessment (OR if patient has died, they were admitted to this site anytime from the...
You likely can't join if
- Potentially eligible participants meeting any of the following criteria at the time of eligibility assessment for platform entry will be excluded...
- Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture (Where the time of culture collection is not...
- Polymicrobial bacteraemia, defined as more than one organism (at species level) in the index blood cultures OR in any subsequent blood culture...
- Known previous participation in the assigned by chance SNAP platform
- Known positive blood culture for S. aureus (of the same silo: PSSA, MSSA or MRSA) between 72 hours and 180 days prior to the time of eligibility...
- Treating team deems enrolment in the study is not in the best interest of the patient
See the full eligibility criteria
Who can join
- PLATFORM Patients must fulfil all of the following criteria to be eligible to enter the SNAP trial:
- Staphylococcus aureus complex grown from ≥1 blood culture
- Admitted to a participating hospital at the time of eligibility assessment (OR if patient has died, they were admitted to this site anytime from the time of blood culture collection until the time of eligibility...
What rules you out
- Potentially eligible participants meeting any of the following criteria at the time of eligibility assessment for platform entry will be excluded from the assigned by chance platform (but may still participate in the...
- Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture (Where the time of culture collection is not recorded, the time of laboratory registration of the sample will be...
- Polymicrobial bacteraemia, defined as more than one organism (at species level) in the index blood cultures OR in any subsequent blood culture reported between the collection of the index blood culture and platform...
- Known previous participation in the assigned by chance SNAP platform
- Known positive blood culture for S. aureus (of the same silo: PSSA, MSSA or MRSA) between 72 hours and 180 days prior to the time of eligibility assessment
- 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 antibiotic treatment is considered not appropriate
- Patient \<18 years of age and paediatric recruitment not approved at recruiting site
- Patient has died since the collection of the index blood culture To be included in any of the following DOMAINS the participant must met eligible for the PLATFORM (as listed above) ADJUNCTIVE TREATMENT DOMAIN Inclusion...
- All participants that met the PLATFORM eligible are eligible to be included in this domain unless they meet any of the following exclusions listed.
- Patients are eligible for this domain regardless of S. aureus susceptibility testing results to clindamycin. Exclusion criteria: 1\. Previous type 1 hypersensitivity reaction to lincosamides 2. Currently receiving...
- For PSSA silo: Index blood culture isolate is penicillin-susceptible as per the Microbiology Appendix. In short, this will require phenotypic disc testing with EUCAST (a P1 disc diffusion with zone \>=26mm OR a P1 disc...
- For MSSA silo: Index blood culture isolate is methicillin-susceptible as per the Microbiology Appendix. Note that where trial sites are not testing for penicillin-susceptibility, patients with MSSA/PRSA can be included...
- \>72 hours have elapsed since the collection of the index blood culture (i.e. the time of collection of the first positive blood culture from the patient during this episode)
- History of type I hypersensitivity reaction (i.e. anaphylaxis or angioedema) to any penicillin or cephalosporin
- History of severe delayed reaction (e.g. allergic interstitial nephritis, cutaneous vasculitis, Stevens-Johnson, DRESS, etc.) to any penicillin or cephalosporin
- PSSA silo: Non-severe rash to any penicillin (unless patient has been subsequently de-labelled; this criteria does not include criteria 2 and 3 above), or MSSA silo: Non-severe rash to cefazolin or any penicillin...
- Treating team deems enrolment in this domain is not in the best interest of the patient
- Currently receiving maintenance dialysis (haemodialysis or peritoneal dialysis); (Acute renal replacement therapy (including CRRT, haemodialysis or peritoneal dialysis) are not exclusions. Such patients are eligible as...
- Polymicrobial bacteraemia (defined as more than one organism [at species level] in blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician)...
- Patient currently being treated with a systemic antibacterial agent that cannot be ceased or substituted for interventions allocated within the platform (unless antibiotic is listed in Table 1 of the DSA, which...
- Time to allocation reveal is \>72 hours from time of index blood culture collection
- Severe allergy to any beta-lactam (including cefazolin) Immediate severe allergy: Anaphylaxis/angioedema Severe delayed allergy: Severe cutaneous adverse reaction (SCAR; including Steven Johnson Syndrome, Toxic...
- Non-severe rash to cefazolin Nausea, diarrhoea, headache and other non-specific symptoms are NOT allergies, they are drug intolerance, and they are not exclusion criteria. Similarly, a vague history of an allergy of...
- Clearance of SAB by platform Day 2: blood cultures negative for S. aureus from platform Day 2 onwards AND no known subsequent positive blood cultures
- Afebrile (\<37.8°C) for the past 72 hours (at time of judging eligibility)
- Primary focus is either line related (either central or peripheral IV cannula) or skin and soft tissue, AND source control achieved (for 'line-related' this means line removed; for 'skin and soft tissue' means site PI...
- No evidence of metastatic foci (on clinical or radiological examination, but radiological imaging is not required to exclude metastatic foci if not clinically indicated) Day 14 (+/- 2 days):
- Clearance of SAB by platform Day 5: blood cultures negative for S. aureus from platform Day 5 (+/-1 day) AND no known subsequent positive blood cultures. If the most recent blood culture from Day 2-4 is negative for S...
- Afebrile (\<37.8°C) for the past 72 hours (at time of judging eligibility)
- Site Principal Investigator has determined that source control is adequate Exclusion Criteria: When judging eligibility at platform Day 7 (+/- 2 days) and at Day 14 (+/- 2 days), exclusion criteria are:
- Adherence to oral agents unlikely (as judged by site PI in consultation with the treating team)
- Unreliable gastrointestinal absorption (e.g. vomiting, diarrhoea, nil by mouth, anatomical reasons)
- There are no appropriate oral antibiotics due to contraindications, drug availability, or antibiotic resistance
- Ongoing IV therapy unsuitable e.g. no IV access
- Clinician deems not appropriate for early oral switch
- Patient no longer willing to participate in domain In the lead-up to judging eligibility, it may be helpful to discuss with the patient the potential for continued IV treatment versus oral switch, to allow hospital...
- Clinical team deems that sufficient duration of antibiotic therapy has already been provided Exclusions when judging eligibility for early oral switch at trial Day 7 (+/- 2 days):
- Presence of prosthetic cardiac valve, pacemaker or other intracardiac implant
- Presence of intravascular clot, graft, or other intravascular prosthetic material Intravascular clot excludes superficial peripheral IV line-related thrombophlebitis. Intravascular prosthetic material excludes coronary...
- Intravascular/intracardiac infections (e.g. endocarditis, mycotic aneurysm)
- Presence of other intracardiac abnormalities felt to put patient at increased risk of endocarditis (e.g., bicuspid aortic valve) PET/CT DOMAIN Inclusion Criteria:
- PET/CT participating site
- Patient is accessible for PET/CT - a patient is considered accessible if the site team are able to access the participant medical records, arrange for a PET/CT scan for the patient, and discuss this domain with the...
- Pregnant - patients of childbearing potential should be assessed for pregnancy status and a pregnancy test performed (if not performed within the past 10 days)
- Currently breastfeeding
- \< 18 years of age
- Patient has had PET/CT in the past 7 days
- Patient needs PET/CT in the next 7 days (in the opinion of the clinical team, at the time of eligibility assessment)
- Clinically unstable for PET/CT (as judged by the treating clinical team, taking into account need for organ support (including inotropes) and capacity to lie flat for the PET/CT)
- Contraindication to PET/CT (e.g., claustrophobia, persistently elevated blood sugar levels [\>12.5mmol/L] that cannot be corrected).
- Patient no longer willing to participate in the domain - in the days leading up to judging eligibility, it may be helpful to discuss with the patient the potential for PET/CT vs no PET/CT to allow imaging planning
- Clinician deems participation in this domain is not in the patient's best interests
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Garran, Australia Capital Territory, Australia
- Blacktown, New South Wales, Australia
- Camperdown, New South Wales, Australia
- Concord, New South Wales, Australia
- Darlinghurst, New South Wales, Australia
- Kingswood, New South Wales, Australia
- Kogarah, New South Wales, Australia
- Liverpool, New South Wales, Australia
- New Lambton Heights, New South Wales, Australia
- Newcastle, New South Wales, Australia
- Orange, New South Wales, Australia
- Randwick, New South Wales, Australia
- Westmead, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Tiwi, Northern Territory, Australia
- Birtinya, Queensland, Australia
- Cairns, Queensland, Australia
- Herston, Queensland, Australia
- Ipswich, Queensland, Australia
+ 103 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Garran, Australia Capital Territory, Australia; Blacktown, New South Wales, Australia; Camperdown, New South Wales, Australia; Concord, New South Wales, Australia; Darlinghurst, New South Wales, Australia and 117 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.