Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA… (NCT01196169) | Clinical Trial Compass
TerminatedPhase 4
Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty
Stopped: The study is closed to accrual. Enrollment of new patients stopped at the request of CUBIST Pharmaceuticals due to slow rate of enrollment.
United States28 participantsStarted 2010-10
Plain-language summary
This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared to another one which is vancomycin when given around the time of joint replacement surgery. Vancomycin is recommended for perioperative prophylaxis in methicillin resistant Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty. Daptomycin has not been recommended for this indication but it is FDA approved for treatment of MRSA blood stream and skin and soft tissue infections. Data collected during this study may support the use of daptomycin for this indication and may also be used for other research purposes that have not yet been specified.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed, and dated informed consent as defined by the Institutional Review Board.
* Male and female patients older than 18 years of age undergoing primary elective hip, knee or shoulder arthroplasty.
* Documented nasal carriage of MRSA.
* If a female of childbearing potential the patient should agree to practice a reliable contraceptive method (e.g. birth control pills, condoms, or intrauterine device \[IUD\]) during treatment and for one month after receiving the study medication.
Exclusion Criteria:
* Concurrent urinary tract infection or colonization unless treated with evidence of microbiologic cure.
* Evidence of active infection elsewhere other than urinary tract, unless treated with evidence of microbiologic cure documented by the infectious diseases service.
* Patients undergoing elective secondary arthroplasty.
* Concurrent open wounds
* Pregnant and nursing women (if patient is still of childbearing potential, a negative serum pregnancy test will be confirmed).
* History of allergy or contraindication to study drugs.
* Weight \>150 kg or \<50kg
* Patients with creatinine clearance (CLcr) \< 30ml/min (calculated using the Cockcroft-Gault equation using ideal body weight)
* Severe neutropenia (absolute neutrophil count \<0.500x103 /µl).
* Patients considered unlikely to comply with study procedures or to return for the scheduled post treatment evaluation.
* Ongoing antibiotic therapy for active infection that is anticipated to continue until th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Daptomycin efficacy in prevention of postoperative surgical site infection (SSI)
Timeframe: 24 months
Trial details
NCT IDNCT01196169
SponsorMountain Home Research & Education Corporation