Staphylococcal InfectionsPhase 4NCT01196169
Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty
A Phase 4 study testing Daptomycin and Vancomycin in people with Staphylococcal Infections and Methicillin-resistant Staphylococcus Aureus, run by Mountain Home Research & Education Corporation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Staphylococcal Infections, Methicillin-resistant Staphylococcus Aureus
- What is being tested?
- Daptomycin and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Mar 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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 the day of surgery.
- Any other condition that in the opinion of the investigator, would confound or interfere with evaluation of safety or efficacy of the investigational medication, or prevent compliance with the study protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johnson City Medical Center
Johnson City, Tennessee, 37604
James H Quillen VA Medical Center
Mountain Home, Tennessee, 37684
About this study
Official title: Daptomycin Use For Prophylaxis In Prosthetic Joint Surgery, A Randomized Prospective Study Comparing The Efficacy Of Daptomycin Versus Vancomycin For Peri-Operative Antibiotic Prophylaxis In MRSA Colonized Adult Patients Undergoing Primary Elective Hip, Knee or Shoulder Arthroplasty
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.
Read the detailed description
This is a phase 4 randomized open label prospective pilot study comparing the use of daptomycin versus vancomycin for peri-operative antibiotic prophylaxis in patients undergoing elective primary knee, hip or shoulder arthroplasty and are at risk for infection with methicillin resistant Staphylococcus aureus. The study population will include males and non-pregnant, non-lactating females 18 years of age or older, with history of methicillin-resistant Staphylococcus aureus infection or colonization, and undergoing primary elective hip, knee or shoulder arthroplasty. The target enrollment is 100 patients, who will be randomized to daptomycin or vancomycin in two 50 patient study groups. After signing the informed consent, patients will undergo pre-enrollment nasal screening for methicillin resistant Staphylococcus aureus to identify eligible patients. Patients with positive MRSA nasal screen will proceed with enrollment and get randomized into one of the two study groups. In one group, patients will receive one dose of daptomycin 6 mg/kg to be infused over 30 minutes. In this group, the infusion should be started and completed within 60 minutes of surgical incision. In the second group, patients will receive one dose of vancomycin 15 mg/kg to be infused over 1-2 hours of surgical incision according to the dose to avoid red man syndrome. In this group, the infusion should be started and completed within 120 minutes of surgical incision. After surgery, a second similar dose of vancomycin will be given 12 hours after the first dose to patients with creatinine clearance (CLcr.) of ≥50 ml/min. All patients in both groups will be asked to shower with chlorhexidine skin cleanser (HIBICLENS®) once daily from the neck down for 7days before surgery and apply Mupirocin ointment 2% to their nostrils twice daily for 5 days before surgery.
The patients will be evaluated on the day of surgery, at 2-3 days postoperatively, on discharge, at one month and three months follow up visits. During these study evaluations, patients will be assessed clinically for signs and symptoms of wound, and prosthetic joint infection (including pain, tenderness, swelling, erythema, poor wound healing and wound drainage) prior to hospital discharge, and at one, and three months follow up visits. Blood work including complete blood counts, erythrocytic sedimentation rate, c-reactive protein, and cultures will be ordered if clinical findings suggest infection. Bacterial isolates causing infections will be tested locally for antibiotic susceptibilities including daptomycin and vancomycin and saved for further testing if needed. Adverse effects and tolerability will be documented with the use of both drugs in the two patient groups. Data will be collected and analyzed with appropriate testing. The primary endpoint will be the success in prevention of postoperative SSI and prosthetic joint infection at one month postoperative follow up visit.
- Being tested
- Daptomycin, Vancomycin
- Keywords
- daptomycin, vancomycin, perioperative, prophylaxis, arthroplasty, prosthesis, preoperative
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Also called Cubicin
One dose of Daptomycin 6 mg/Kg iv, will be infused over 30 minutes. The infusion will start no longer than one hour prior to surgical incision of primary knee or hip prosthetic joint arthroplasty.
VancomycinDrug
Two doses of vancomycin 15 mg/Kg iv, with a maximum of 2 grams with each dose be infused over 60-120 minutes according to the dose. The first dose infusion will start no longer than one hour (if ≤ one gram), or no longer than two hours (if > one gram) prior to surgical incision of primary knee or hip prosthetic joint arthroplasty. A second similar dose will be given 12 hours after the first dose unless the patient has a creatinine clearance of < 50 ml/min. Patients with creatinine clearance of < 50 ml/min will only receive one dose.
| Study group | Role | What they receive |
|---|---|---|
| Daptomycin | Experimental | Half of patients anticipated to be enrolled will receive daptomycin in antimicrobial prophylaxis prior to their prosthetic joint surgery. Receives: Drug: Daptomycin |
| Vancomycin | Active comparator | Half of patients anticipated to be enrolled will receive vancomycin in antimicrobial prophylaxis prior to their prosthetic joint surgery. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daptomycin efficacy in prevention of postoperative surgical site infection (SSI)
Efficacy of daptomycin in preventing postoperative SSI will be determined for each enrolled subject on one month postoperative visit. Overall efficacy of daptomycin among the patient group who receive it will be compared to overall efficacy of vancomycin among the second patient group who receive vancomycin upon anticipated complete enrollment study at 24 months.
Measured: 24 months
Secondary outcomes (1)
Efficacy of daptomycin in preventing postoperative early prosthetic joint infection
Efficacy of daptomycin in preventing postoperative early prosthetic joint infection will be determined for each enrolled subject on three months postoperative visit. Overall efficacy of daptomycin among the patient group who receive it will be compared to overall efficacy of vancomycin among the second patient group who receive vancomycin upon anticipated completion of the study at 30 months
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Why it stopped: The study is closed to accrual. Enrollment of new patients stopped at the request of CUBIST Pharmaceuticals due to slow rate of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Staphylococcal InfectionsStudies 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mountain Home Research & Education Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- East Tennessee State University, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Sponsor
- Investigators
- Wael E Shams, M.D., Principal investigator, James H Quillen VA Medical Center and East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196169
- Sponsor's protocol ID
- 0310.7f
- Status last verified
- Jan 2014
- First submitted
- 4 Jun 2010
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bratzler DW, Houck PM; Surgical Infection Prevention Guidelines Writers Workgroup; American Academy of Orthopaedic Surgeons; American Association of Critical Care Nurses; American Association of Nurse Anesthetists; American College of Surgeons; American College of Osteopathic Surgeons; American Geriatrics Society; American Society of Anesthesiologists; American Society of Colon and Rectal Surgeons; American Society of Health-System Pharmacists; American Society of PeriAnesthesia Nurses; Ascension Health; Association of periOperative Registered Nurses; Association for Professionals in Infection Control and Epidemiology; Infectious Diseases Society of America; Medical Letter; Premier; Society for Healthcare Epidemiology of America; Society of Thoracic Surgeons; Surgical Infection Society. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004 Jun 15;38(12):1706-15. doi: 10.1086/421095. Epub 2004 May 26.
PubMed 15227616Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. doi: 10.1056/NEJMra040181. No abstract available.
PubMed 15483283Price CS, Williams A, Philips G, Dayton M, Smith W, Morgan S. Staphylococcus aureus nasal colonization in preoperative orthopaedic outpatients. Clin Orthop Relat Res. 2008 Nov;466(11):2842-7. doi: 10.1007/s11999-008-0337-x. Epub 2008 Jun 19.
PubMed 18563506Lamp KC, Friedrich LV, Mendez-Vigo L, Russo R. Clinical experience with daptomycin for the treatment of patients with osteomyelitis. Am J Med. 2007 Oct;120(10 Suppl 1):S13-20. doi: 10.1016/j.amjmed.2007.07.010.
PubMed 17904946Marculescu CE, Osmon DR. Antibiotic prophylaxis in orthopedic prosthetic surgery. Infect Dis Clin North Am. 2005 Dec;19(4):931-46. doi: 10.1016/j.idc.2005.07.002.
PubMed 16297740
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daptomycin Use For Prophylaxis In Prosthetic Joint Surgery, A Randomized Prospective Study Comparing The Efficacy Of Daptomycin Versus Vancomycin For Peri-Operative Antibiotic Prophylaxis In MRSA Colonized Adult Patients Undergoing Primary Elective Hip, Knee or Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT01196169
- Acronym / sponsor ID
- 0310.7f
- Keywords
- daptomycin, vancomycin, perioperative, prophylaxis, arthroplasty, prosthesis, preoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is closed to accrual. Enrollment of new patients stopped at the request of CUBIST Pharmaceuticals due to slow rate of enrollment.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mountain Home Research & Education CorporationUniversity, hospital or other
- Collaborators
- East Tennessee State University, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- Oct 2010
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 8 Sep 2010 (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.
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.
Detailed description
This is a phase 4 randomized open label prospective pilot study comparing the use of daptomycin versus vancomycin for peri-operative antibiotic prophylaxis in patients undergoing elective primary knee, hip or shoulder arthroplasty and are at risk for infection with methicillin resistant Staphylococcus aureus. The study population will include males and non-pregnant, non-lactating females 18 years of age or older, with history of methicillin-resistant Staphylococcus aureus infection or colonization, and undergoing primary elective hip, knee or shoulder arthroplasty. The target enrollment is 100 patients, who will be randomized to daptomycin or vancomycin in two 50 patient study groups. After signing the informed consent, patients will undergo pre-enrollment nasal screening for methicillin resistant Staphylococcus aureus to identify eligible patients. Patients with positive MRSA nasal screen will proceed with enrollment and get randomized into one of the two study groups. In one group, patients will receive one dose of daptomycin 6 mg/kg to be infused over 30 minutes. In this group, the infusion should be started and completed within 60 minutes of surgical incision. In the second group, patients will receive one dose of vancomycin 15 mg/kg to be infused over 1-2 hours of surgical incision according to the dose to avoid red man syndrome. In this group, the infusion should be started and completed within 120 minutes of surgical incision. After surgery, a second similar dose of vancomycin will be given 12 hours after the first dose to patients with creatinine clearance (CLcr.) of ≥50 ml/min. All patients in both groups will be asked to shower with chlorhexidine skin cleanser (HIBICLENS®) once daily from the neck down for 7days before surgery and apply Mupirocin ointment 2% to their nostrils twice daily for 5 days before surgery.
The patients will be evaluated on the day of surgery, at 2-3 days postoperatively, on discharge, at one month and three months follow up visits. During these study evaluations, patients will be assessed clinically for signs and symptoms of wound, and prosthetic joint infection (including pain, tenderness, swelling, erythema, poor wound healing and wound drainage) prior to hospital discharge, and at one, and three months follow up visits. Blood work including complete blood counts, erythrocytic sedimentation rate, c-reactive protein, and cultures will be ordered if clinical findings suggest infection. Bacterial isolates causing infections will be tested locally for antibiotic susceptibilities including daptomycin and vancomycin and saved for further testing if needed. Adverse effects and tolerability will be documented with the use of both drugs in the two patient groups. Data will be collected and analyzed with appropriate testing. The primary endpoint will be the success in prevention of postoperative SSI and prosthetic joint infection at one month postoperative follow up visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daptomycin | Experimental | Drug: DaptomycinHalf of patients anticipated to be enrolled will receive daptomycin in antimicrobial prophylaxis prior to their prosthetic joint surgery. |
| Vancomycin | Active comparator | Drug: VancomycinHalf of patients anticipated to be enrolled will receive vancomycin in antimicrobial prophylaxis prior to their prosthetic joint surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
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 |
|---|---|---|
| DaptomycinAlso: CubicinOne dose of Daptomycin 6 mg/Kg iv, will be infused over 30 minutes. The infusion will start no longer than one hour prior to surgical incision of primary knee or hip prosthetic joint arthroplasty. | Drug | Daptomycin |
| VancomycinTwo doses of vancomycin 15 mg/Kg iv, with a maximum of 2 grams with each dose be infused over 60-120 minutes according to the dose. The first dose infusion will start no longer than one hour (if ≤ one gram), or no longer than two hours (if > one gram) prior to surgical incision of primary knee or hip prosthetic joint arthroplasty. A second similar dose will be given 12 hours after the first dose unless the patient has a creatinine clearance of < 50 ml/min. Patients with creatinine clearance of < 50 ml/min will only receive one dose. | Drug | Vancomycin |
Primary outcome
Daptomycin efficacy in prevention of postoperative surgical site infection (SSI)
Time frame: 24 months
Efficacy of daptomycin in preventing postoperative SSI will be determined for each enrolled subject on one month postoperative visit. Overall efficacy of daptomycin among the patient group who receive it will be compared to overall efficacy of vancomycin among the second patient group who receive vancomycin upon anticipated complete enrollment study at 24 months.
1 secondary outcome
Efficacy of daptomycin in preventing postoperative early prosthetic joint infection
Time frame: 30 months
Results and safety
The study was stopped early (reason given: The study is closed to accrual. Enrollment of new patients stopped at the request of CUBIST Pharmaceuticals due to slow rate of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
- Background: PubMed 15227616Bratzler DW, Houck PM; Surgical Infection Prevention Guidelines Writers Workgroup; American Academy of Orthopaedic Surgeons; American Association of Critical Care Nurses; American Association of Nurse Anesthetists; American College of Surgeons; American College of Osteopathic Surgeons; American Geriatrics Society; American Society of Anesthesiologists; American Society of Colon and Rectal Surgeons; American Society of Health-System Pharmacists; American Society of PeriAnesthesia Nurses; Ascension Health; Association of periOperative Registered Nurses; Association for Professionals in Infection Control and Epidemiology; Infectious Diseases Society of America; Medical Letter; Premier; Society for Healthcare Epidemiology of America; Society of Thoracic Surgeons; Surgical Infection Society. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004 Jun 15;38(12):1706-15. doi: 10.1086/421095. Epub 2004 May 26.
- Background: PubMed 15483283Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. doi: 10.1056/NEJMra040181. No abstract available.
- Background: PubMed 18563506Price CS, Williams A, Philips G, Dayton M, Smith W, Morgan S. Staphylococcus aureus nasal colonization in preoperative orthopaedic outpatients. Clin Orthop Relat Res. 2008 Nov;466(11):2842-7. doi: 10.1007/s11999-008-0337-x. Epub 2008 Jun 19.
- Background: PubMed 17904946Lamp KC, Friedrich LV, Mendez-Vigo L, Russo R. Clinical experience with daptomycin for the treatment of patients with osteomyelitis. Am J Med. 2007 Oct;120(10 Suppl 1):S13-20. doi: 10.1016/j.amjmed.2007.07.010.
- Background: PubMed 16297740Marculescu CE, Osmon DR. Antibiotic prophylaxis in orthopedic prosthetic surgery. Infect Dis Clin North Am. 2005 Dec;19(4):931-46. doi: 10.1016/j.idc.2005.07.002.
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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.
Wael E Shams, M.D. principal investigator
James H Quillen VA Medical Center and East Tennessee State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daptomycin and Vancomycin in people with Staphylococcal Infections and Methicillin-resistant Staphylococcus Aureus, run by Mountain Home Research & Education Corporation at 2 sites 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: The study is closed to accrual. Enrollment of new patients stopped at the request of CUBIST Pharmaceuticals due to slow rate of enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daptomycin efficacy in prevention of postoperative surgical site infection (SSI) (time frame: 24 months). 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 NCT01196169, which also lists 5 linked publications.
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 3 Feb 2014; AzTrials last refreshed its copy on 30 Oct 2026.