Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA

NCT01419184 | Completed Phase 4 Results

• 2 other identifiers: 3009-015DAP-HEOR-10-06
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 26

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.

Conditions

Staphylococcal Skin Infections

Keywords

Complicated Skin and Skin Structure Infections (cSSSI); Methicillin-resistant Staphylococcus aureus (MRSA); Daptomycin; Vancomycin; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Infection-Related Hospital Length of Stay

  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.

  Baseline (Day 0) through the End of Hospital Stay (up to Day 14)

Secondary Outcomes (5)

• Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF)

  Baseline (Day 0), End of Hospital Stay (up to Day 14)

• Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL)

  Baseline (Day 0), End of Hospital Stay (up to Day 14)

• Participant Global Impression of Improvement (PGI-I) at Hospital Discharge

  End of Hospital Stay (up to Day 14)

• 30-day cSSSI-related Hospital Readmission Rates

  End of Hospital Stay (up to Day 14) through 30 days post hospital discharge

• cSSSI-related Medical Resource Utilization and Costs

  Baseline (Day 0) through 30 days post hospital discharge

Study Arms (2)

Daptomycin

EXPERIMENTAL

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

Vancomycin

ACTIVE COMPARATOR

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

Interventions

Daptomycin DRUG

Also known as: Cubicin

Daptomycin

Vancomycin DRUG

Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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
• 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
• Are suspected or documented to be caused by MRSA
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Study Sites (26)

Unknown Facility

Mobile, Alabama, United States

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Chula Vista, California, United States

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Escondido, California, United States

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La Mesa, California, United States

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Oceanside, California, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Waterloo, Iowa, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Royal Oak, Michigan, United States

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Minneapolis, Minnesota, United States

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Las Vegas, Nevada, United States

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Albany, New York, United States

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East Meadow, New York, United States

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Mineola, New York, United States

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The Bronx, New York, United States

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Winston-Salem, North Carolina, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Rapid City, South Dakota, United States

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Austin, Texas, United States

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Ponce, Puerto Rico

Location

Related Publications (1)

• Kauf TL, McKinnon P, Corey GR, Bedolla J, Riska PF, Sims M, Jauregui-Peredo L, Friedman B, Hoehns JD, Mercier RC, Garcia-Diaz J, Brenneman SK, Ng D, Lodise T. An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection. BMC Infect Dis. 2015 Nov 7;15:503. doi: 10.1186/s12879-015-1261-9.

  PMID: 26547411 DERIVED

MeSH Terms

Conditions

Staphylococcal Skin Infections

Interventions

Daptomycin; Vancomycin

Condition Hierarchy (Ancestors)

Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Glycopeptides; Glycoconjugates; Carbohydrates

Results Point of Contact

• Title: Vice President, Clinical Research
• Organization: Cubist Pharmaceuticals

1.781.860.8660

Study Officials

• Cubist Pharmaceuticals Medical Monitor Medical Monitor

  Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 18, 2011
• Study Start: September 9, 2011
• Primary Completion: September 1, 2012
• Study Completion: October 5, 2012
• Last Updated: September 5, 2018
• Results First Posted: July 8, 2015

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

US (25); PR (1)