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Anti-biotic

Daptomycin vs. Vancomycin for Staph Bacteremia (DAPTO-SNAP Trial)

Phase 4
Recruiting
Led By Todd C Lee, MD MPH FIDSA
Research Sponsored by Todd C. Lee MD MPH FIDSA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Methicillin-resistant S. aureus bacteremia
Be older than 18 years old
Must not have
Known vancomycin minimum inhibitory concentration (MIC) greater than or equal to 2mg/L or daptomycin MIC greater than or equal to 1mg/L
Suspected or confirmed MRSA pneumonia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90 post enrollment in the s. aureus network adaptive platform trial (nct05137119)
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will compare two common treatments, vancomycin and daptomycin, for patients with MRSA bloodstream infection. It is part of a larger approved study called The Staphylococcus

Who is the study for?
This trial is for patients with a serious blood infection caused by a bacteria called methicillin-resistant Staphylococcus aureus (MRSA). It's open to those who haven't been treated yet. Specific eligibility details are not provided, but typically participants need to meet certain health standards.
What is being tested?
The study compares two drugs: Daptomycin and Vancomycin, both given through injection. It aims to find out which one is better at treating MRSA bloodstream infections. Patients will be randomly assigned to receive one of the treatments.
What are the potential side effects?
Possible side effects from these antibiotics may include digestive issues, potential kidney damage, muscle pain or weakness, and infusion-related reactions. Each person might experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a blood infection caused by MRSA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My infection is resistant to common antibiotics.
Select...
I have or might have pneumonia caused by MRSA.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90 post enrollment in the s. aureus network adaptive platform trial (nct05137119)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 post enrollment in the s. aureus network adaptive platform trial (nct05137119) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Desirability of Outcome Ranking (DOOR)
Secondary study objectives
All cause mortality
Clinical failure
Drug Induced Myostitis
+3 more

Side effects data

From 2020 Phase 2 trial • 18 Patients • NCT03643952
11%
Pyrexia
11%
Rash
6%
Enterocolitis
6%
Platelet count increased
6%
Infusion site swelling
6%
Gastrointestinal mucosal disorder
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Genital candidiasis
6%
Cough
6%
Acne
6%
Gastroenteritis viral
6%
Chills
6%
Catheter site related reaction
6%
Injection site pain
6%
Weight decreased
6%
Alopecia
6%
Hypertension
6%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daptomycin

Awards & Highlights

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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DaptomycinExperimental Treatment1 Intervention
Daptomycin given by injection at a dose determined by the treating clinicians but no less than 6mg/kg
Group II: VancomycinActive Control1 Intervention
Vancomycin given by injection at a dose determined by the treating clinicians to achieve a trough-based or AUC-based target
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daptomycin for Injection
2018
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Todd C. Lee MD MPH FIDSALead Sponsor
2 Previous Clinical Trials
360 Total Patients Enrolled
2 Trials studying Staphylococcus Aureus Endocarditis
360 Patients Enrolled for Staphylococcus Aureus Endocarditis
The Peter Doherty Institute for Infection and ImmunityOTHER
16 Previous Clinical Trials
13,324 Total Patients Enrolled
University of MelbourneOTHER
182 Previous Clinical Trials
1,281,950 Total Patients Enrolled
1 Trials studying Staphylococcus Aureus Endocarditis
300 Patients Enrolled for Staphylococcus Aureus Endocarditis
Todd C Lee, MD MPH FIDSAPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
4 Previous Clinical Trials
730 Total Patients Enrolled
2 Trials studying Staphylococcus Aureus Endocarditis
360 Patients Enrolled for Staphylococcus Aureus Endocarditis
~200 spots leftby Jan 2027
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