Staphylococcus Aureus Network Adaptive Platform Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
University of Melbourne
Study ID
NCT05137119
Phase
PHASE4
Status
Recruiting
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Conditions

  • Staphylococcus Aureus Bacteremia

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cefazolin — DRUG
    Cefazolin
  • Penicillin — DRUG
    benzylpenicillin
  • Clindamycin — DRUG
    Clindamycin
  • Vancomycin — DRUG
    Vancomycin or Daptomycin
  • Effectiveness of early switch to oral antibiotics — OTHER
    This involves testing a strategy rather than individual antibiotic agents
  • Whole body FDG PET/CT Imaging — RADIATION
    Whole body FDG PET/CT imaging will be performed using a standardised protocol describing patient preparation and minimum specifications for radiopharmaceutical production, quality control, and PET/CT acquisition.

Study Details

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 Dates

Start date
Feb 16, 2022
Status verified
Jul 2025
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
8,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: Methicillin-resistant staphylococcus aureus (MRSA) - Standard Therapy Arm (backbone therapy)
    Vancomycin or Daptomycin - Standard Therapy Arm Either intravenous vancomycin dosed as per Australian Therapeutic Guidelines: This includes a loading dose of 25 mg/kg (up to 3000mg) if considered appropriate by the treating clinician, initial maintenance dosing at 15-20 mg/kg q12h, with subsequent adjustment to maintain area under the concentration-time curve (AUC) of 400 to 600 mg.hr/L OR trough levels at 10-20 mg/L, and the initial level taken 48-72 hours after the initiation of the first dose. Daptomycin 8-10mg/kg per day intravenously. The choice of vancomycin or daptomycin will be at the clinician's discretion. Dosing will be based on renal function.
  • Experimental: Methicillin-resistant staphylococcus aureus (MRSA) - Standard + B-Lactam Arm (backbone therapy)
    Vancomycin or Daptomycin (Standard Therapy) + Beta-Lactam (β-lactam) Arm In addition to standard treatment an intravenous β-lactam will be added for the first 7 calendar days following randomisation (day 1 being the day of randomisation - hence patients will receive 6-7 days of β-lactam). This β-lactam will be intravenous cefazolin 2g every 8 hours. For patients with renal impairment the intravenous cefazolin administration doses will be adjusted.
  • No Intervention: Methicillin-susceptible staphylococcus aureus (MSSA) - Standard Therapy Arm (backbone therapy)
    Flucloxacillin or cloxacillin - Standard Therapy Arm Either intravenous flucloxacillin/cloxacillin 2g every 4 or 6 hours. The minimum protocol duration of allocated study treatment is 14 days for those not allocated to early oral switch, and 5 days for those allocated to early oral switch. For patients with renal impairment or critical illness the intravenous flucloxacillin administration dose will be adjusted.
  • Experimental: Methicillin-susceptible staphylococcus aureus (MSSA) - Interventional Arm (backbone therapy)
    Cefazolin - Interventional Arm Intravenous cefazolin 2g every 6 or 8 hours. The minimum protocol duration of allocated study treatment is 14 days for those not allocated to early oral switch, and 5 days for those allocated to early oral switch. For patients with renal impairment or critical illness the intravenous cefazolin administration dose will be adjusted.
  • No Intervention: Penicillin-susceptible staphylococcus aureus (PSSA) - Standard Therapy Arm (backbone therapy)
    Flucloxacillin or cloxacillin - Standard Therapy Arm Either intravenous flucloxacillin/cloxacillin 2g every 4 or 6 hours. The minimum protocol duration of allocated study treatment is 14 days for those not allocated to early oral switch, and 5 days for those allocated to early oral switch. For patients with renal impairment or critical illness the intravenous flucloxacillin administration dose will be adjusted.
  • Experimental: Penicillin-susceptible staphylococcus aureus (PSSA) - Interventional Arm (backbone therapy)
    Benzylpenicillin - Interventional Arm Intravenous benzylpenicillin 1.8g (3 million units) every 4 or 6 hours. The minimum protocol duration of allocated study treatment is 14 days for those not allocated to early oral switch, and 5 days for those allocated to early oral switch. For patients with critical illness the intravenous benzylpenicillin administration doses will be adjusted.
  • No Intervention: No adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy arm
    No adjunctive therapy + backbone therapy arm for MRSA or MSSA or PSSA Participants with either MRSA or MSSA or PSSA will have no adjunctive therapy in combination with their backbone therapy arm.
  • Experimental: Adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy arm
    Adjunctive therapy + backbone therapy arm for MRSA or MSSA or PSSA Intravenous clindamycin (or lincomycin) 600mg every 8 hours from platform day 1 to day 5. No dosage adjustment is needed to renal impairment.
  • No Intervention: Continue intravenous antibiotic therapies (backbone +/- adjunctive therapy) - standard of care arm
    Backbone therapy arm for MRSA or MSSA or PSSA +/- adjunctive therapy will continue on intravenous antibiotic treatment for the length of time as per usual standard of care. Participants eligibility is assessed at Day 7 (+/- 2 days) if eligible will be randomised if not eligible then eligibility will be assess again at Day 14(+/- 2 days). If eligibility is not met at day 14 then participant is excluded from this domain.
  • Experimental: Switch to oral antibiotics at trial day 7 (+/- 2 days) or Day 14 (+/- 2 days) if eligible.
    Switch from intravenous backbone antibiotic for MRSA or MSSA or PSSA to oral antibiotics at the treating clinicians discretion on trial Day 7 (+/- 2 days) or trial Day 14 (+/- 2 days). Participants eligibility is assessed at Day 7 (+/- 2 days). If eligible will be randomised, if not eligible then eligibility will be assessed again at Day 14 (+/- 2 days). If eligibility is not met at day 14 then participant is excluded from this domain.
  • No Intervention: No PET/CT scan - standard of care arm
    Participants will not receive a PET/CT scan, in addition to their allocated treatment interventions. Participants eligibility is assessed at Day 7 (+/- 2 days) if eligible will be randomised. If eligibility is not met then participant is excluded from this domain.
  • Experimental: PET/CT scan at trial day 7 (+/- 2 days) if eligible
    Participant will receive a PET/CT scan at Day 5-12, in addition to their allocated treatment interventions. Participants eligibility is assessed at Day 7 (+/- 2 days) if eligible will be randomised. If eligibility is not met then participant is excluded from this domain.

Primary Outcome Measure

All-cause mortality at 90 days after platform entry [ Time Frame: From randomisation (day 1) until day 90 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Research InstituteHoustonTexas77030
Cesar Arias
[email protected]
346-651-8674

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Houston Methodist Research Institute· Houston, TX

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