MRSA - Methicillin Resistant Staphylococcus Aureus InfectionPhase 4NCT01612052
Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)
A Phase 4 study testing Antibiotic Prophylaxis in people with MRSA - Methicillin Resistant Staphylococcus Aureus Infection, run by CAMC Health System at 1 site in United States.
Trial summary
The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive bacteria, and some gram-negative bacteria which may not be adequate antibiotic treatment at the time of vascular surgery and result in an… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- MRSA - Methicillin Resistant Staphylococcus Aureus Infection
- What is being tested?
- Antibiotic Prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Any elective arterial revascularization procedure involving one or more groin plus lower extremity incisions
- Further, patient's considered at high risk because of history of MRSA colonization or infection, HIV, admission for >3 months in an acute care center or long-term care center will be included in the study.
Who cannot join
- Patient with an allergy to Cefazolin, Daptomycin or Vancomycin.
- Patients allergic to Penicillin.
- Patients enrolled in another IRB approved biomedical study.
- Patients with active infection requiring antibiotics preoperatively.
Trial locations and contacts
1 site in 1 country.
Patrick Stone, M.D. contact
United States1 site, 1 recruiting
- Recruiting
Vascular Center of Excellence
Charleston, West Virginia, 25304
Patrick Stone, M.D., 304-388-8250 ext. 9901
Steven Hass, M.D.
About this study
Official title: Double Blinded Prospective Randomized Controlled Trial Comparing Cefazolin Plus Vancomycin Versus Cefazolin Plus Daptomycin for Vascular Surgery Prophylaxis
The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive bacteria, and some gram-negative bacteria which may not be adequate antibiotic treatment at the time of vascular surgery and result in an increased hospital length of stay, increased cost of care, and an increased risk of morbidity and mortality as a consequence of surgical site infections. Thus, the investigators want to compare whether Methicillin-resistant Staphylococcus Aureaus (MRSA) antibiotic prophylaxis with Cefazolin plus Daptomycin is superior to Cefazolin plus Vancomycin in the reduction of surgical site infection (SSI) following open arterial revascularization procedures requiring a groin plus lower extremity incision. The investigators hypothesis is that Cefazolin plus Daptomycin is superior to Cefazolin plus Vancomycin in the prevention of SSI for high risk patients undergoing open groin plus lower extremity procedures.
Read the detailed description
There is an increase in surgical site infection (SSI) due to MRSA. The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive bacteria, and some gram-negative bacteria. To demonstrate that MRSA coverage is needed in vascular surgery with prosthetic graft placement in areas of the body that is at high risk for infection, the investigators are initiating a second study of patients undergoing groin plus lower extremity procedures by using combination antibiotics such as Cefazolin plus Daptomycin, Cefazolin plus Vancomycin. By decreasing post surgical site and prosthetic infections, the investigators could significantly reduce vascular surgery mortality and morbidity. Cost and amputation rates the investigators feel could also be reduced. Patients will be randomized in two groups -- Cefazolin plus Daptomycin, Cefazolin plus Vancomycin and will be evaluated during post procedure before discharge or within 30 days and between 30 and 360 days, for postoperative complications including cellulitis, graft infection, sepsis, limb loss, graft failure, and length of stay. If a patient is re-hospitalized, reason for the return and whether it is related to the procedure will be evaluated. Additionally, is there a graft failure, amputation, infection, hematoma, pseudoanurysm will be assessed. In case of a wound infection, the type of organism and finally, length of this hospitalization will be recorded.
- Being tested
- Antibiotic Prophylaxis
- Keywords
- Vascular Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic ProphylaxisDrug
Comparing the antibiotic treatment related to surgery
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin plus Daptomycin | Active comparator | Not described Receives: Drug: Antibiotic Prophylaxis |
| Cefazolin plus Vancomycin | Active comparator | Not described Receives: Drug: Antibiotic Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between number of patients with MRSA infection between two groups
Measured: post procedure at 30 days
Secondary outcomes (1)
Difference between number of patients with post-op complications between two groups
Measured: post procedure at 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMay 2011
- Primary completionMar 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MRSA - Methicillin Resistant Staphylococcus Aureus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Stone, MD, CAMC Health System
- Investigators
- Patrick Stone, M.D., Principal investigator, CAMC Medical Staff-with admitting privileges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612052
- Sponsor's protocol ID
- 1997028
- Status last verified
- Feb 2013
- First submitted
- 1 Sep 2011
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
PubMed 41159585
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Prospective Randomized Controlled Trial Comparing Cefazolin Plus Vancomycin Versus Cefazolin Plus Daptomycin for Vascular Surgery Prophylaxis
- ClinicalTrials.gov ID
- NCT01612052
- Acronym / sponsor ID
- 1997028
- Keywords
- Vascular Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive bacteria, and some gram-negative bacteria which may not be adequate antibiotic treatment at the time of vascular surgery and result in an increased hospital length of stay, increased cost of care, and an increased risk of morbidity and mortality as a consequence of surgical site infections. Thus, the investigators want to compare whether Methicillin-resistant Staphylococcus Aureaus (MRSA) antibiotic prophylaxis with Cefazolin plus Daptomycin is superior to Cefazolin plus Vancomycin in the reduction of surgical site infection (SSI) following open arterial revascularization procedures requiring a groin plus lower extremity incision. The investigators hypothesis is that Cefazolin plus Daptomycin is superior to Cefazolin plus Vancomycin in the prevention of SSI for high risk patients undergoing open groin plus lower extremity procedures.
Detailed description
There is an increase in surgical site infection (SSI) due to MRSA. The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive bacteria, and some gram-negative bacteria. To demonstrate that MRSA coverage is needed in vascular surgery with prosthetic graft placement in areas of the body that is at high risk for infection, the investigators are initiating a second study of patients undergoing groin plus lower extremity procedures by using combination antibiotics such as Cefazolin plus Daptomycin, Cefazolin plus Vancomycin. By decreasing post surgical site and prosthetic infections, the investigators could significantly reduce vascular surgery mortality and morbidity. Cost and amputation rates the investigators feel could also be reduced. Patients will be randomized in two groups -- Cefazolin plus Daptomycin, Cefazolin plus Vancomycin and will be evaluated during post procedure before discharge or within 30 days and between 30 and 360 days, for postoperative complications including cellulitis, graft infection, sepsis, limb loss, graft failure, and length of stay. If a patient is re-hospitalized, reason for the return and whether it is related to the procedure will be evaluated. Additionally, is there a graft failure, amputation, infection, hematoma, pseudoanurysm will be assessed. In case of a wound infection, the type of organism and finally, length of this hospitalization will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefazolin plus Daptomycin | Active comparator | Drug: Antibiotic Prophylaxis |
| Cefazolin plus Vancomycin | Active comparator | Drug: Antibiotic Prophylaxis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 years
- Any elective arterial revascularization procedure involving one or more groin plus lower extremity incisions
- Further, patient's considered at high risk because of history of MRSA colonization or infection, HIV, admission for >3 months in an acute care center or long-term care center will be included in the study.
Key exclusion criteria (4 listed)
- Patient with an allergy to Cefazolin, Daptomycin or Vancomycin.
- Patients allergic to Penicillin.
- Patients enrolled in another IRB approved biomedical study.
- Patients with active infection requiring antibiotics preoperatively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic ProphylaxisComparing the antibiotic treatment related to surgery | Drug | Cefazolin plus Daptomycin, Cefazolin plus Vancomycin |
Primary outcome
Difference between number of patients with MRSA infection between two groups
Time frame: post procedure at 30 days
1 secondary outcome
Difference between number of patients with post-op complications between two groups
Time frame: post procedure at 360 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Derived from this study: PubMed 41159585Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Stone, M.D. contact
Patrick Stone, M.D. principal investigator
CAMC Medical Staff-with admitting privileges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotic Prophylaxis in people with MRSA - Methicillin Resistant Staphylococcus Aureus Infection, run by CAMC Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Stone, M.D. (304-388-8250 ext. 9901), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between number of patients with MRSA infection between two groups (time frame: post procedure at 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01612052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.