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Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA (DAPHEOR1006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01419184
Recruitment Status : Completed
First Posted : August 18, 2011
Results First Posted : July 8, 2015
Last Update Posted : September 5, 2018
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Brief Summary:
This was a real-world, prospective, open-label, multicenter study in which participants were randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin. The purpose of this study is to compare infection-related hospital length of stay, along with a number of participant-reported outcomes, between participants with complicated skin and soft tissue infection treated with daptomycin and vancomycin.

Condition or disease Intervention/treatment Phase
Staphylococcal Skin Infections Drug: Daptomycin Drug: Vancomycin Phase 4

Detailed Description:
Eligible participants will be recruited within 24 hours of hospital admission for cSSSI due to suspected or documented Methicillin-resistant Staphylococcus Aureus (MRSA), and who are anticipated to require IV antibiotics effective against MRSA and at least 3 days of hospitalization for management of cSSSI. The primary objective is to compare infection-related hospital length of stay between participants treated with daptomycin and vancomycin. Secondary objectives were to compare participant reported outcomes (pain symptoms and Health Related Quality of Life), 30 day cSSSI-related hospital readmission rates, and cSSSI-related medical resource utilization and costs between participants treated with daptomycin and vancomycin.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study to Evaluate Comparative Effectiveness, Inpatient Resource Utilization, and Cost of Daptomycin vs. Vancomycin in the Treatment of Patients With Complicated Skin and Skin Structure Infections Due to Suspected or Documented Methicillin-resistant Staphylococcus Aureus (MRSA)
Actual Study Start Date : September 9, 2011
Actual Primary Completion Date : September 1, 2012
Actual Study Completion Date : October 5, 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Daptomycin
4 milligrams per kilogram (mg/kg) daptomycin administered intravenously (IV) once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
Drug: Daptomycin
Other Name: Cubicin

Active Comparator: Vancomycin
Vancomycin was reconstituted per the manufacturer's instructions and was dosed per investigator's discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion
Drug: Vancomycin

Primary Outcome Measures :
  1. Infection-Related Hospital Length of Stay [ Time Frame: Baseline (Day 0) through the End of Hospital Stay (up to Day 14) ]
    Infection Related Hospital Length of Stay (IRLOS) is defined as the number of hours of hospitalization associated with antibiotic treatment of the complicated skin and skin structure infections (cSSSI) beginning at initiation of study-antibiotic administration and ending at discontinuation of all antibiotic therapy for cSSSI or at hospital discharge (whichever occurred first). This included continued hospitalization for treatment of adverse events resulting from use of the study antibiotic or subsequent antimicrobial therapy. The mean number of hours for each treatment group is presented.

Secondary Outcome Measures :
  1. Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Baseline (Day 0), End of Hospital Stay (up to Day 14) ]
    Pain was measured as the amount of pain experienced "right now" by the participant using an 11-point numerical rating scale adapted from Brief Pain Inventory-Short Form (BPI-SF). Participants were asked to rate pain in his or her skin infection from 0 to 10, where 0 is no pain and 10 is pain as bad as he or she could imagine. Change from baseline to hospital discharge is presented; a negative value represents a decrease in pain.

  2. Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL) [ Time Frame: Baseline (Day 0), End of Hospital Stay (up to Day 14) ]
    Health-related quality of life (HRQoL) was measured using the EuroQol-5 Dimensions, 5 Level (EQ-5D-5L) multi-attribute questionnaire. The 5 dimensions measured were: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant's health state was expressed by a descriptive profile of a 5 digit number. The EQ-5D health states were converted into a single summary index (from 0 to 1, with 0 representing death, to 1 representing perfect health) by applying weights to each of the levels in each dimension. Change from baseline to hospital discharge is presented; positive values represent an increase in health utility.

  3. Participant Global Impression of Improvement (PGI-I) at Hospital Discharge [ Time Frame: End of Hospital Stay (up to Day 14) ]
    PGI-I assessments of improvement were measured by asking participants: How is your skin infection today compared to how it was yesterday? Scores were calculated based on response to the single item, where 1 = improved a lot; 2 = improved moderately; 3 = improved a little; 4 = no change; 5 = worsened a little; 6 = worsened moderately; 7 = worsened a lot. Mean PGI-I scores are presented at hospital discharge; lower values represent greater improvement.

  4. 30-day cSSSI-related Hospital Readmission Rates [ Time Frame: End of Hospital Stay (up to Day 14) through 30 days post hospital discharge ]
    Hospital readmission rates were defined as readmission to an inpatient hospital facility within 30 days of hospital discharge for management of cSSSI relapse or treatment of adverse events related to cSSSI treatment. It did not include all-cause readmissions (for completeness, all-cause readmissions are reported in the descriptive tables). Participants were asked if they had been readmitted to the hospital since their discharge and whether the admission was specifically for their skin infection. The number of participants who were re-hospitalized for skin infection or side effects due to skin infection medication within 30 days since the initial hospital discharge (Day 14) is presented.

  5. cSSSI-related Medical Resource Utilization and Costs [ Time Frame: Baseline (Day 0) through 30 days post hospital discharge ]
    Direct medical costs were based on utilization of health resources. Unit cost data were obtained from sources external to the trial and assigned to corresponding medical resource utilization observed within the trial to estimate costs of care. cSSSI-related costs were reported from a societal perspective, and further broken down into a health care system perspective. The health care system perspective includes hospital and outpatient costs. The societal perspective includes the health care system perspective plus participant and caregiver time loss from work and participant and caregiver out-of-pocket expenses. Total cost (including both total inpatient and total post-discharge costs) per participant is presented.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ≥18 years of age
  • Primary reason for hospitalization is skin and skin structure infection of a complicated nature (for example, cellulitis/erysipelas, major cutaneous abscess, or wound infection) that requires IV antibiotic treatment for an anticipated 3 to14 days and hospitalization for management

    1. Further defined as infections either involving deeper soft tissue or requiring significant surgical intervention or infections in which the participant has a significant underlying disease state that complicates the response to treatment
    2. Are suspected or documented to be caused by MRSA
    3. At least 3 of the following clinical signs and symptoms associated with the cSSSI:

    i. Pain; tenderness to palpation; ii. Elevated temperature (>37.5°Celsius [99.5° Farenheit] oral or >38° Celsius [100.2° Farenheit] rectal); iii. Elevated white blood count (WBC) >10,000/millimeters cubed (mm^3); iv. Swelling and/or induration; erythema; v. Purulent or seropurulent drainage or discharge

  • Physician determination that vancomycin or daptomycin would be the initial treatment of choice for the cSSSI under study (or meets institutional criteria for use of vancomycin or daptomycin)
  • Informed consent obtained and signed
  • Less than 24 hours post hospital admission

Exclusion Criteria:

  • Participants with known bacteremia, osteomyelitis, septic arthritis, or endocarditis
  • Conditions where surgery (in and of itself) constitutes curative treatment of the infection (for example, amputation, incision and drainage)
  • cSSSIs which can be managed with an oral antibiotic
  • Participants where hospitalization is expected to be <48 hours
  • Nosocomial infection
  • Participants with necrotizing infections or concomitant gangrene
  • Use of systemic antibacterial therapy for the infection for > 24 hours within 48 hours prior to the start of study drug unless (a) the infecting Gram-positive pathogen was resistant in vitro to the therapy or (b) the therapy was administered for 3 or more days with either worsening or no improvement in the infection
  • Pathogens identified at study entry to be nonsusceptible to daptomycin or vancomycin
  • Participants with neutropenia or compromised immune function (that is, severe neutropenia [absolute neutrophil count <500 cells per microliter (μL)] or is anticipated to develop severe neutropenia during the study period due to prior or planned therapy)
  • Renal insufficiency (calculated creatinine clearance [CLcr] <30 milliliters per minute or on dialysis)
  • Known to be allergic or intolerant to daptomycin or vancomycin
  • Pregnant or nursing mothers
  • Suspected implanted device or prosthetic as source of infection
  • Is considered unlikely to comply with study procedures or to be available for follow-up contact

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01419184

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United States, Alabama
Mobile, Alabama, United States
United States, California
Chula Vista, California, United States
Escondido, California, United States
La Mesa, California, United States
Oceanside, California, United States
United States, Georgia
Augusta, Georgia, United States
Decatur, Georgia, United States
United States, Iowa
Waterloo, Iowa, United States
United States, Kansas
Topeka, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
Royal Oak, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Albany, New York, United States
Bronx, New York, United States
East Meadow, New York, United States
Mineola, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Columbus, Ohio, United States
Toledo, Ohio, United States
United States, South Dakota
Rapid City, South Dakota, United States
United States, Texas
Austin, Texas, United States
Puerto Rico
Ponce, Puerto Rico
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
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Study Director: Cubist Pharmaceuticals Medical Monitor Medical Monitor Cubist Pharmaceuticals LLC
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Cubist Pharmaceuticals LLC Identifier: NCT01419184    
Other Study ID Numbers: 3009-015
DAP-HEOR-10-06 ( Other Identifier: Cubist Study Number )
First Posted: August 18, 2011    Key Record Dates
Results First Posted: July 8, 2015
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
Keywords provided by Cubist Pharmaceuticals LLC:
Complicated Skin and Skin Structure Infections (cSSSI)
Methicillin-resistant Staphylococcus aureus (MRSA)
Additional relevant MeSH terms:
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Communicable Diseases
Skin Diseases, Infectious
Staphylococcal Skin Infections
Connective Tissue Diseases
Pathologic Processes
Skin Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Anti-Bacterial Agents
Anti-Infective Agents