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Staphylococcal Skin InfectionsPhase 4DAPHEOR1006NCT01419184

Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA

A Phase 4 study testing Daptomycin and Vancomycin in people with Staphylococcal Skin Infections, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 26 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Staphylococcal Skin Infections
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
250 participants
Where
26 sitesin 2 countries
Study dates
9 Sep 2011to 5 Oct 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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:
  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States25 sites

  • Study site

    Albany, New York

  • Study site

    Augusta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Chula Vista, California

  • Study site

    Columbus, Ohio

  • Study site

    Decatur, Georgia

  • Study site

    Detroit, Michigan

  • Study site

    East Meadow, New York

  • Study site

    Escondido, California

  • Study site

    La Mesa, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Louisville, Kentucky

  • Study site

    Mineola, New York

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mobile, Alabama

  • Study site

    New Orleans, Louisiana

  • Study site

    Oceanside, California

  • Study site

    Rapid City, South Dakota

  • Study site

    Royal Oak, Michigan

  • Study site

    The Bronx, New York

  • Study site

    Toledo, Ohio

  • Study site

    Topeka, Kansas

  • Study site

    Waterloo, Iowa

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Worcester, Massachusetts

Other trials in United States

Puerto Rico1 site

  • Study site

    Ponce

Other trials in Puerto Rico

About this study

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)

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.

Read the 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.

Being tested
Daptomycin, Vancomycin
Keywords
Complicated Skin and Skin Structure Infections (cSSSI), Methicillin-resistant Staphylococcus aureus (MRSA), Daptomycin, Vancomycin, Antibiotics
Medical subject headings
Staphylococcal Skin Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01419184
Study groupRoleWhat they receive
DaptomycinExperimental4 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.
Receives: Drug: Daptomycin
VancomycinActive comparatorVancomycin 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
Receives: Drug: Vancomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

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

    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.

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

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

    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.

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

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

    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.

    Measured: End of Hospital Stay (up to Day 14)

  4. 30-day cSSSI-related Hospital Readmission Rates

    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.

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

  5. cSSSI-related Medical Resource Utilization and Costs

    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.

    Measured: Baseline (Day 0) through 30 days post hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2011 (estimated)
  2. Study start9 Sep 2011
  3. Primary completion1 Sep 2012
  4. Study completion5 Oct 2012

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01419184
Sponsor's protocol ID
3009-015
Other IDs
DAP-HEOR-10-06
Acronym
DAPHEOR1006
Status last verified
Aug 2018
First submitted
16 Aug 2011
Last updated
5 Sep 2018
Data monitoring committee
No
Individual data sharing
Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 26547411

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Daptomycin and Vancomycin in people with Staphylococcal Skin Infections, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 26 sites in 2 countries.

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 9 inclusion and 14 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: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 8 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Infection-Related Hospital Length of Stay (time frame: Baseline (Day 0) through the End of Hospital Stay (up to Day 14)). 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 NCT01419184, 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 5 Sep 2018.

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