Staphylococcus Aureus Network Adaptive Platform Trial

Recruiting now · Phase 4

Conditions studied: Staphylococcus Aureus Bacteremia

In brief

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).

Key facts

Study ID

NCT05137119

Run by

University of Melbourne

People needed

8000

Starts

2022-02-16

Expected to finish

2028-12-01

Last updated by the study team

2026-05-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Previous type 1 hypersensitivity reaction to lincosamides 2. Currently receiving clindamycin (lincomycin) or linezolid which cannot be ceased or substituted 3. Necrotising fasciitis 4. Current C. difficile associated diarrhoea (any severity) 5. Current severe diarrhoea from any cause (defined as Grade 3 or higher) 5. Known CDAD (C.Difficile Associated Diarrhoea) in the past 3 months, or CDAD relapse in the past 12 months 6. At the time of domain eligibility assessment, more than 4 hours has elapsed since platform entry 7. Treating clinician deems enrolment in this domain is not in the best interest of the patient
• PSSA, MSSA TREATMENT DOMAIN (backbone)
• Inclusion Criteria:
• 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 diffusion with zone >=26mm and the zone edge is NOT sharp) OR CLSI (a P10 disc diffusion) defined criteria.
• 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 in the MSSA silo, but those with MSSA/PSSA (but not confirmed with a P-disc) will be excluded from the backbone domain. The rationale for this is that patients with MSSA but not tested with a P-disc may be truly PSSA (with no blaZ). If the cefazolin inoculum effect (CIE) is a clinically relevant entity, then including patients with an organism without blaZ (and hence cannot have a CIE phenotype), will bias towards non-inferiority of cefazolin compared to (flu)cloxacillin.
• For PSSA, the requirement for laboratories to use an accredited phenotypic test for a penicillin-susceptible phenotype, is to ensure clinical safety according to internationally accepted guidelines. The automated antimicrobial susceptibility testing, and other phenotypic tests, have poor sensitivity for detection of blaZ compared to a gold standard of blaZ PCR. Therefore, patients could be placed at risk of treatment with benzylpenicillin when the infecting isolate is actually blaZ positive, unless these guidelines are followed.
• Exclusion Criteria (PSSA \& MSSA):
• >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 (unless patient has been subsequently de-labelled); (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 unclear nature, or a family history of allergy are not exclusions.)
• 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 long as appropriate vascular access is available or can be arranged.)
• 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) reported between collection of the index blood culture and backbone domain eligibility assessment
• 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 specifies allowed antibiotics with limited absorption from the gastrointestinal tract or negligible antimicrobial activity against S. aureus)
• MRSA TREATMENT DOMAIN (backbone)
• Inclusion Criteria:
• MRSA confirmed microbiologically
• Exclusion Criteria:
• 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 Epidermal Necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP)), severe drug induced liver injury, proven allergic interstitial nephritis, immune-mediated haemolytic anaemia and other severe cytopenia.
• 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 unclear nature, or a family history of allergy are not exclusions.)
• Severe allergy or non-severe rash to both vancomycin AND daptomycin Vancomycin infusion reaction (formerly known as "red man syndrome") is due to direct histamine release and is not generally an allergy, and therefore is not considered an exclusion.
• Treating team deems enrolment in the domain is not in the best interest of the patient 6. 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) reported between collection of the index blood culture and backbone domain eligibility assessment.

Where it is running

• Queensland Children's Hospital — South Brisbane, Queensland, Australia (enrolling)
• Blacktown Hospital — Blacktown, New South Wales, Australia (enrolling)
• Canberra Hospital — Garran, Australia Capital Territory, Australia (enrolling)
• Houston Methodist Research Institute — Houston, Texas, United States (enrolling)
• St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (enrolling)
• Nepean Hospital — Kingswood, New South Wales, Australia (enrolling)
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (enrolling)
• Liverpool Hospital — Liverpool, New South Wales, Australia (enrolling)
• John Hunter Hospital — New Lambton Heights, New South Wales, Australia (enrolling)
• Concord Repatriation and General Hospital — Concord, New South Wales, Australia (enrolling)
• Orange Health Service — Orange, New South Wales, Australia (enrolling)
• Prince of Wales Hospital — Randwick, New South Wales, Australia (enrolling)
• Sydney Children's Hospital — Randwick, New South Wales, Australia (enrolling)
• The Children's Hospital at Westmead — Westmead, New South Wales, Australia (enrolling)
• Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
• Wollongong Hospital — Wollongong, New South Wales, Australia (enrolling)
• Royal Darwin Hospital — Tiwi, Northern Territory, Australia (enrolling)
• Sunshine Coast University Hospital — Birtinya, Queensland, Australia (enrolling)
• Cairns Hospital — Cairns, Queensland, Australia (enrolling)
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia (enrolling)
• Ipswich Hospital — Ipswich, Queensland, Australia (enrolling)
• John Hunter Children's Hospital — Newcastle, New South Wales, Australia (enrolling)
• Redcliffe Hospital — Redcliffe, Queensland, Australia (enrolling)
• Robina Hospital — Robina, Queensland, Australia (enrolling)
• Gold Coast University Hospital — Southport, Queensland, Australia (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.