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First Generation Cephalosporin
Antibiotics for Staph Infection (SNAP Trial)
Phase 4
Recruiting
Research Sponsored by University of Melbourne
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For PSSA silo: Index blood culture is penicillin-susceptible
For MSSA silo: Index blood culture isolate is methicillin-susceptible but penicillin resistant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomisation (day 1) until day 14, 28, and 42
Awards & highlights
SNAP Trial Summary
This trial is testing different ways to reduce the death rate for people with a Staphylococcus Aureus infection.
Who is the study for?
This trial is for patients with a Staphylococcus aureus infection in their blood, who are currently admitted to a hospital participating in the study. It's not specified who can't join because the exclusion criteria are missing.Check my eligibility
What is being tested?
The SNAP trial is testing several antibiotics (Penicillin, Clindamycin, Vancomycin, Cefazolin) and strategies like switching to oral antibiotics early on to see which reduces mortality in Staph bloodstream infections.See study design
What are the potential side effects?
Common side effects of these antibiotics may include allergic reactions, gastrointestinal issues like diarrhea or nausea, kidney problems with vancomycin, and possible antibiotic resistance.
SNAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood culture is sensitive to penicillin.
Select...
My infection is resistant to penicillin but can be treated with methicillin.
SNAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomisation (day 1) until day 14, 28, and 42
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomisation (day 1) until day 14, 28, and 42
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All-cause mortality at 90 days after platform entry
Secondary outcome measures
All-cause mortality at 14, 28 and 42 days after platform entry
C. difficile diarrhoea as determined by a clinical laboratory in the 90 days following platform entry for participants ≥2 years of age.
Desirability of outcome ranking 1 (modified Antibiotic Resistance Leadership Group version)
+10 moreSNAP Trial Design
10Treatment groups
Experimental Treatment
Active Control
Group I: Switch to oral antibiotics at trial day 7 (+/- 2 days) or Day 14 (+/- 2 days) if eligible.Experimental Treatment1 Intervention
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.
Group II: Penicillin-susceptible staphylococcus aureus (PSSA) - Interventional Arm (backbone therapy)Experimental Treatment1 Intervention
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.
Group III: Methicillin-susceptible staphylococcus aureus (MSSA) - Interventional Arm (backbone therapy)Experimental Treatment1 Intervention
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.
Group IV: Methicillin-resistant staphylococcus aureus (MRSA) - Standard + B-Lactam Arm (backbone therapy)Experimental Treatment2 Interventions
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.
Group V: Adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy armExperimental Treatment1 Intervention
Adjunctive therapy + backbone therapy arm for MRSA or MSSA or PSSA Intravenous clindamycin (or lincomycin) 600mg every 8 hours for 5 days. No dosage adjustment is needed to renal impairment.
Group VI: Methicillin-resistant staphylococcus aureus (MRSA) - Standard Therapy Arm (backbone therapy)Active Control1 Intervention
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.
Group VII: Penicillin-susceptible staphylococcus aureus (PSSA) - Standard Therapy Arm (backbone therapy)Active Control1 Intervention
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.
Group VIII: Methicillin-susceptible staphylococcus aureus (MSSA) - Standard Therapy Arm (backbone therapy)Active Control1 Intervention
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.
Group IX: Continue intravenous antibiotic therapies (backbone +/- adjunctive therapy) - standard of care armActive Control1 Intervention
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.
Group X: No adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy armActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cefazolin
2017
Completed Phase 4
~4720
Clindamycin
2017
Completed Phase 4
~14740
Vancomycin
2005
Completed Phase 4
~7930
Find a Location
Who is running the clinical trial?
University of MelbourneLead Sponsor
166 Previous Clinical Trials
1,281,440 Total Patients Enrolled
Berry ConsultantsOTHER
14 Previous Clinical Trials
50,181 Total Patients Enrolled
Tan Tock Seng HospitalOTHER
140 Previous Clinical Trials
7,274,451 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 and the site does not approve pediatric patients.I have issues absorbing medications due to my stomach or bowel.I cannot receive treatments through IV.I am currently taking clindamycin or linezolid and cannot stop or change it.I have heart abnormalities that could increase my risk of heart infection.I am receiving end-of-life care and antibiotics are not suitable for me.I have a blood clot or a graft inside my blood vessels.I cannot take oral antibiotics due to allergies, availability, or resistance.My infection is clearing, I've been fever-free for 3 days, and any infection source has been treated.I am currently experiencing severe diarrhea or diarrhea caused by C. difficile.I have been diagnosed with necrotizing fasciitis.I am on antibiotics that can't be stopped, but they aren't for S. aureus.I do not have any infections inside my blood vessels or heart.My doctor thinks this trial is not right for me.I am on regular dialysis treatment.My blood culture is sensitive to penicillin.I no longer wish to participate in the study.I have had C.Diff associated diarrhea recently or a relapse within the last year.My infection is resistant to penicillin but can be treated with methicillin.
Research Study Groups:
This trial has the following groups:- Group 1: Switch to oral antibiotics at trial day 7 (+/- 2 days) or Day 14 (+/- 2 days) if eligible.
- Group 2: Methicillin-resistant staphylococcus aureus (MRSA) - Standard Therapy Arm (backbone therapy)
- Group 3: Penicillin-susceptible staphylococcus aureus (PSSA) - Standard Therapy Arm (backbone therapy)
- Group 4: Methicillin-susceptible staphylococcus aureus (MSSA) - Standard Therapy Arm (backbone therapy)
- Group 5: Adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy arm
- Group 6: Continue intravenous antibiotic therapies (backbone +/- adjunctive therapy) - standard of care arm
- Group 7: Methicillin-susceptible staphylococcus aureus (MSSA) - Interventional Arm (backbone therapy)
- Group 8: Penicillin-susceptible staphylococcus aureus (PSSA) - Interventional Arm (backbone therapy)
- Group 9: No adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy arm
- Group 10: Methicillin-resistant staphylococcus aureus (MRSA) - Standard + B-Lactam Arm (backbone therapy)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant count for this research endeavor?
"Affirmative. According to the clinicaltrials.gov website, this medical study is actively recruiting participants since its initial posting on February 16th 2022 and subsequent update a week later. The trial has an ambitious goal of enrolling 6000 patients from across 16 different locations."
Answered by AI
Is there potential for harm when transitioning to oral antibiotics at an early stage?
"The safety of this early switch to oral antibiotics was rated a 3 as it has already been approved in Phase 4 trials."
Answered by AI
How many medical centers are conducting the experiment?
"16 sites are currently enrolling patients, including the McGill University Health Centre in Montréal, Unity Health in Toronto and the University of Calgary - Foothills Medical Center."
Answered by AI
How efficacious is the transition to oral antibiotics for common ailments?
"The efficacy of prompt transition to oral antibiotics is commonly employed in the context of surgical prophylaxis therapy. Additionally, these same medications can be utilised for treating bacterial endocarditis, staphylococcal infections and anaerobic bacteria."
Answered by AI
What other studies have been undertaken to assess the efficacy of transitioning to oral antibiotics swiftly?
"Presently, 89 clinical studies are in progress to assess the efficacy of transitioning to oral antibiotics early. Of these trials, 16 are currently at Phase 3 and most take place in Los Angeles, California. However, there are 400 other locations across the United States that have research projects assessing Effectiveness of early switch to oral antibiotics underway."
Answered by AI
Are participants currently being enrolled in this experiment?
"According to information on clinicaltrials.gov, this medical study is actively seeking out participants for enrollment. The trial was initially advertised on February 16th 2022 and the details were most recently updated on February 23rd 2022."
Answered by AI
Who else is applying?
What site did they apply to?
Vancouver General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
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