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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

Must not have

Patient <18 years of age and paediatric recruitment not approved at recruiting site

Unreliable gastrointestinal absorption (e.g. vomiting, diarrhoea, nil by mouth, anatomical reasons)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomisation (day 1) until day 14, 28, and 42

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood culture is sensitive to penicillin.

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My infection is resistant to penicillin but can be treated with methicillin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 and the site does not approve pediatric patients.

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I have issues absorbing medications due to my stomach or bowel.

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I cannot receive treatments through IV.

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I am currently taking clindamycin or linezolid and cannot stop or change it.

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I have heart abnormalities that could increase my risk of heart infection.

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I am receiving end-of-life care and antibiotics are not suitable for me.

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I have a blood clot or a graft inside my blood vessels.

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I am currently experiencing severe diarrhea or diarrhea caused by C. difficile.

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I have been diagnosed with necrotizing fasciitis.

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I do not have any infections inside my blood vessels or heart.

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I am on regular dialysis treatment.

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I have had C.Diff associated diarrhea recently or a relapse within the last year.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomisation (day 1) until day 14, 28, and 42 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All-cause mortality at 90 days after platform entry

Secondary study objectives

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.

Days alive and free of antibiotics

+12 more

Awards & Highlights

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.

Trial Design

12Treatment 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: PET/CT scan at trial day 7 (+/- 2 days) if eligibleExperimental Treatment1 Intervention

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.

Group IV: 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 V: 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 VI: 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 from platform day 1 to day 5. No dosage adjustment is needed to renal impairment.

Group VII: No PET/CT scan - standard of care armActive Control1 Intervention

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.

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: Penicillin-susceptible staphylococcus aureus (PSSA) - Standard Therapy Arm (backbone therapy)Active Control1 Intervention

Group X: 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 XI: 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 XII: 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

~4610

Clindamycin

2017

Completed Phase 4

~14760