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Staphylococcus Aureus Network Adaptive Platform Trial
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).
Study details:
Infection of the bloodstream with the bacterium Staphylococcus aureus (Staphylococcus aureus bacteraemia, SAB) is a serious infection that results in 15-30% of affected patients dying within three months of acquiring the infection. Treatment of this infection requires patients to be hospitalised, treated with prolonged antibiotics through an intravenous line, and carefully examined for the occurrence of complications associated with this condition. At present, there are many treatment options in current use, with no clear agreement as to which of these is best.
The SNAP trial aims to identify which treatment options for SAB results in the fewest patients dying within the first 90 days after an infection. In contrast to a conventional clinical trial, the SNAP trial will examine multiple different treatment options at once. Patients will be randomly assigned to different concurrent treatment options currently considered acceptable in routine medical care, but as the trial progresses, more patients will be assigned to treatments that appear to have better outcomes than those with worse outcomes.
The trial will adapt to accumulating trial evidence, on a regular basis, by removing treatment options found to be inferior, incorporating new treatment options, and ensuring that all patients in the trial receive the best treatments once they have been identified. Over time, we hope to determine the best combination of treatment options for patients with SAB. The SNAP Trial infrastructure will also support a number of sub-studies.
A list of all active sub-studies can be found on the SNAP website: https://www. snaptrial. com.
au/substudies.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Eligibility
Age eligible for study : 0 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-02-16
Primary completion: 2028-12-01
Study completion finish: 2028-12-01
Study type
TREATMENT
Phase
PHASE4
Trial ID
NCT05137119
Intervention or treatment
DRUG: Cefazolin
DRUG: Penicillin
DRUG: Clindamycin
DRUG: Vancomycin
OTHER: Effectiveness of early switch to oral antibiotics
RADIATION: Whole body FDG PET/CT Imaging
Conditions
- • Staphylococcus Aureus Bacteremia
Find a site
Closest Location:
Blacktown Hospital
Research sites nearby
Select from list below to view details:
Blacktown Hospital
Blacktown, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
NO_INTERVENTION: Methicillin-resistant staphylococcus aureus (MRSA) - Standard Therapy Arm (backbone therapy)
| Not specified |
EXPERIMENTAL: Methicillin-resistant staphylococcus aureus (MRSA) - Standard + B-Lactam Arm (backbone therapy)
| DRUG: Cefazolin
|
NO_INTERVENTION: Methicillin-susceptible staphylococcus aureus (MSSA) - Standard Therapy Arm (backbone therapy)
| Not specified |
EXPERIMENTAL: Methicillin-susceptible staphylococcus aureus (MSSA) - Interventional Arm (backbone therapy)
| DRUG: Cefazolin
|
NO_INTERVENTION: Penicillin-susceptible staphylococcus aureus (PSSA) - Standard Therapy Arm (backbone therapy)
| Not specified |
EXPERIMENTAL: Penicillin-susceptible staphylococcus aureus (PSSA) - Interventional Arm (backbone therapy)
| DRUG: Penicillin
|
NO_INTERVENTION: No adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy arm
| Not specified |
EXPERIMENTAL: Adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy arm
| DRUG: Clindamycin
|
NO_INTERVENTION: Continue intravenous antibiotic therapies (backbone +/- adjunctive therapy) - standard of care arm
| Not specified |
EXPERIMENTAL: Switch to oral antibiotics at trial day 7 (+/- 2 days) or Day 14 (+/- 2 days) if eligible.
| OTHER: Effectiveness of early switch to oral antibiotics
|
NO_INTERVENTION: No PET/CT scan - standard of care arm
| Not specified |
EXPERIMENTAL: PET/CT scan at trial day 7 (+/- 2 days) if eligible
| RADIATION: Whole body FDG PET/CT Imaging
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
All-cause mortality at 90 days after platform entry | The primary endpoint for all cells and domains will be all-cause mortality at 90 days after platform entry. The primary endpoint will be determined through a search of hospital databases for a record of a participant's death, or follow-up contact with the participant's community healthcare provider, or follow-up contact with the patient or their nominated carer, or linkage with death registries. | From randomisation (day 1) until day 90 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
All-cause mortality at 14, 28 and 42 days after platform entry | Determined through a search of hospital databases for a record of a participant's death, or follow-up contact with the participant's community healthcare provider, or follow-up contact with the patient or their nominated carer, or linkage with death registries. | From randomisation (day 1) until day 14, 28, and 42 |
Duration of survival censored at 90 days after platform entry | Determined through a search of hospital databases for a record of a participant's death, or follow-up contact with the participant's community healthcare provider, or follow-up contact with the patient or their nominated carer, or linkage with death registries. | From randomisation (day 1) until day 90 |
Length of stay of acute index inpatient hospitalisation for those surviving until discharge from acute inpatient facilities (excluding HITH/COPAT/OPAT/rehab). | Acute index hospitalisation is defined as continuous hospital admission to one or more acute inpatient facilities for the index episode. This does not include HITH/OPAT/COPAT and stepdown inpatient rehabilitation/post-acute care. It does include admission to acute care hospitals immediately preceding and following those at the enrolling site. | From randomisation (day 1) until discharge from acute inpatient facilities, truncated at 90 days. |
Length of stay of total index hospitalisation for those surviving until hospital discharge (including HITH/COPAT/OPAT/rehab) | Total index hospitalisation is defined as continuous hospital admission to one or more inpatient facilities for the index episode, including HITH/OPAT/COPAT and stepdown inpatient rehabilitation/post-acute care (if continuous with the initial inpatient admission). It includes admission to acute care hospitals immediately preceding and following those at the enrolling site. | From randomisation (day 1) to discharge from total index hospitalisation, truncated at 90 days |
Time to being discharged alive from the total index hospitalisation (including HITH/COPAT/OPAT/rehab) truncated at 90 days after platform entry | and all deaths within 90 days will be considered '90 days' | From randomisation (day 1) to discharge from total index hospitalisation, truncated at 90 days |
Microbiological treatment failure defined as positive sterile site culture for S. aureus [of the same silo as the index isolate between 14 and 90 days after platform entry). | A sterile site means any sites deep to the skin and skin structures, including deep visceral and musculoskeletal abscesses that have been obtained in a sterile manner. | From randomisation (day 1) until day 90 |
Diagnosis of new foci between 14 and 90 days after platform entry. | The presence of new foci will be determined by the site investigator and can incorporate clinical, radiological, microbiological and pathological findings. | From randomisation (day 1) until day 90 |
C. difficile diarrhoea as determined by a clinical laboratory in the 90 days following platform entry for participants ≥2 years of age. | This means a stool submitted to a clinical laboratory has tested positive for C. difficile toxin or toxin gene. | From randomisation (day 1) until day 90 |
Number of participants with Serious adverse reactions (SARs) in the 90 days following platform entry | SARs defined only as events that are attributable to one or more study interventions | From randomisation (day 1) until day 90 |
Health economic costs as detailed in the cost utility analysis appendix. | Including hospital length of stay, readmissions, and patient employment status. | From randomisation (day 1) until day 90 |
Proportion of participants who have returned to their usual level of function at day 90. | Determined by whether the modified functional bloodstream infection score (FBIS) remained the same or improved between baseline and 90 days after platform entry. | From randomisation (day 1) until day 90 |
Desirability of outcome ranking 1 (modified Antibiotic Resistance Leadership Group version) | unable to insert modified ARLG table | From randomisation (day 1) until day 90 |
Desirability of outcome ranking 2 (SNAP version) | unable to insert SNAP DOOR table | From randomisation (day 1) until day 90 |
Number of antibiotic days (IV and/or oral/enteral) | All days on which any antibiotic dose is received should be counted - i.e. we are counting the number of whole or part days on which any antibiotics are received (not the number of defined daily doses of antibiotics). Topical, inhaled or other routes of administration besides IV or oral/enteral should not be counted. | From randomisation (day 1) until day 90 |
Days alive and free of antibiotics | All antibiotics should be included, not only those intended for treatment of S. aureus bacteraemia. It also includes prophylactic dose antibiotics (e.g., prophylactic dose trimethoprim-sulfamethoxazole) | From randomisation (day 1) until day 90 |
Frequently Asked Questions
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