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Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-economic Comparison of Daptomycin vs. Vancomycin Based Regimens

Primary Purpose

Diabetic Foot

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cubicin
Vancomycin
Sponsored by
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-80 who are able to give informed consent and, who are likely to be able to participate through the full 28 day of the study.
  • Previously diagnosed diabetes mellitus, requiring the use of insulin and/or oral hypoglycemic agents for glycemic control.
  • The presence of an infection of one or both feet (defined as being distal to the superior-most point of the lateral malleolus), with some drainage, abscess or fluid collection that can be cultured, yet which as not been treated for greater than 24 hours with prior oral antibiotic therapy within the last 48 hours, wand which does not include either a quinolone or linezolid. The foot lesion, in the opinion of the initial treating physician, is severe enough (either because of the lesion or because of the subject's diabetic control, vasculopathy, etc) to require intravenous antibiotics.
  • A culture of the wound, either at the time of screening or within the 72 hours prior to screening, that yields a Gram positive organism that is shown to be sensitive (or is likely to be sensitive) to both vancomycin and daptomycin. This will include Staphylococcus aureus, (including MSSA and MRSA, but excluding VRSA), Enterococcus faecalis and enterococcus faecium (excluding VRE), streptococci, including Groups A and B, as well as other beta-hemolytic streptococci, viridans streptococci, and Group D. A culture of coagulase negative staphylococci as the only Gram positive isolate will not be considered for participation. Cultures may be obtained as swab or fluid submitted for culture.
  • Able to read and write in English with a proficiency suitable for completing the pharmaco-economic and quality of life questionnaires and diaries.

Exclusion Criteria:

  • No Gram positive bacteria identified in the infected foot, infection with a Gram positive organism that is resistant to one of the two study drugs, or infection with coagulase negative staphylococci as the only Gram positive organism isolated.
  • Known hypersensitivity to either of the two proposed study agents, or to ciprofloxacin, if a second anti-microbial agent is necessary.
  • Renal dysfunction, such that the study subject requires dialysis.
  • The presence of active osteomyelitis in the foot.
  • The presence of concomitant infections that would require antibiotic therapy in addition to that being prescribed for the foot infection.
  • The presence of pneumonitis requiring antimicrobial therapy, regardless of the suspected etiologic organism.
  • A history of drug induced ototoxicity (either auditory or vestibular).
  • A history of previous or current vascular catheter-associated phlebitis.
  • Pregnancy or breastfeeding.
  • Alcohol or drug use which, in the opinion of the investigator, is likely to interfere with the conduct of the study.

Sites / Locations

  • Clinical Alliance for Research & Education, Infectious Diseases, LlC
  • Infuscience

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

daptomycin

vancomycin

Arm Description

Dosed at 6mg/kg body weight intravenously every 24 hours with a reduction to 6mg/kg every other day if creatinine clearance (CrCl)is <30ml/min.

Dosed at 15mg/kg intravenously every 12 hours with adjustments for renal function.

Outcomes

Primary Outcome Measures

Pharmaco-economic
Based upon 2 economic parameters associated with the treatment of the infection (provider charges and out-of-pocket costs) from screening until Day 28. Provider charges, as documented in invoices submitted to the pt's. insurance company, will be collected for all activities and services provided by the physician's office,home infusion company, laboratory, etc. during the study period. Out of pocket costs will be captured in a pt. diary and will include any health related costs that are borne by the pt. during the study period. Costs and charges will be analyzed and reported separately.

Secondary Outcome Measures

Quality of Life/patient satisfaction
QOL and pt. satisfaction with the medication, the clinical care, and the overall experience of the infection and its therapy are captured using three study intstruments, which are described in more detail in the Data Collection Instruments section. These include two validated, standardized QOL instruments administred at Baseline, at two weeks and again at 4 weeks, and a pt. satisfaction survey administered at Baseline, 2 and 4 weeks.

Full Information

First Posted
May 28, 2010
Last Updated
September 9, 2013
Sponsor
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Collaborators
Cubist Pharmaceuticals LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01133600
Brief Title
Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-economic Comparison of Daptomycin vs. Vancomycin Based Regimens
Official Title
Phase IV Study of the Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-Economic Comparison of Daptomycin vs Vancomycin Based Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of patient enrollment
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Collaborators
Cubist Pharmaceuticals LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate the overall burden to the participant (economic, quality of life, patients satisfaction and freedom from side effects) when treating Gram positive infections of the foot in diabetic adults with daptomycin versus vancomycin.
Detailed Description
to compare the overall economic burden of therapy of a daptomycin vs. a vancomycin based antibiotic regimen for diabetic foot infections in the outpatient setting to compare Quality of Life and patient satisfaction among recipients of a daptomycin vs. a vancomycin based regimen to compare the safety and tolerance (adverse experiences) of daptomycin vs. vancomycin based regimens to compare the efficacy (complete resolution of infection) of daptomycin vs. vancomycin based regimens

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
daptomycin
Arm Type
Active Comparator
Arm Description
Dosed at 6mg/kg body weight intravenously every 24 hours with a reduction to 6mg/kg every other day if creatinine clearance (CrCl)is <30ml/min.
Arm Title
vancomycin
Arm Type
Active Comparator
Arm Description
Dosed at 15mg/kg intravenously every 12 hours with adjustments for renal function.
Intervention Type
Drug
Intervention Name(s)
Cubicin
Intervention Description
dosed at 6 mg/kg body weight intravenously every 24 hours with a reduction to 6mg/kg every other day if CrCl is <30ml/min.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
dosed at 15mg/kg intravenously every 12 hours with adjustments for renal function.
Primary Outcome Measure Information:
Title
Pharmaco-economic
Description
Based upon 2 economic parameters associated with the treatment of the infection (provider charges and out-of-pocket costs) from screening until Day 28. Provider charges, as documented in invoices submitted to the pt's. insurance company, will be collected for all activities and services provided by the physician's office,home infusion company, laboratory, etc. during the study period. Out of pocket costs will be captured in a pt. diary and will include any health related costs that are borne by the pt. during the study period. Costs and charges will be analyzed and reported separately.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Quality of Life/patient satisfaction
Description
QOL and pt. satisfaction with the medication, the clinical care, and the overall experience of the infection and its therapy are captured using three study intstruments, which are described in more detail in the Data Collection Instruments section. These include two validated, standardized QOL instruments administred at Baseline, at two weeks and again at 4 weeks, and a pt. satisfaction survey administered at Baseline, 2 and 4 weeks.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-80 who are able to give informed consent and, who are likely to be able to participate through the full 28 day of the study. Previously diagnosed diabetes mellitus, requiring the use of insulin and/or oral hypoglycemic agents for glycemic control. The presence of an infection of one or both feet (defined as being distal to the superior-most point of the lateral malleolus), with some drainage, abscess or fluid collection that can be cultured, yet which as not been treated for greater than 24 hours with prior oral antibiotic therapy within the last 48 hours, wand which does not include either a quinolone or linezolid. The foot lesion, in the opinion of the initial treating physician, is severe enough (either because of the lesion or because of the subject's diabetic control, vasculopathy, etc) to require intravenous antibiotics. A culture of the wound, either at the time of screening or within the 72 hours prior to screening, that yields a Gram positive organism that is shown to be sensitive (or is likely to be sensitive) to both vancomycin and daptomycin. This will include Staphylococcus aureus, (including MSSA and MRSA, but excluding VRSA), Enterococcus faecalis and enterococcus faecium (excluding VRE), streptococci, including Groups A and B, as well as other beta-hemolytic streptococci, viridans streptococci, and Group D. A culture of coagulase negative staphylococci as the only Gram positive isolate will not be considered for participation. Cultures may be obtained as swab or fluid submitted for culture. Able to read and write in English with a proficiency suitable for completing the pharmaco-economic and quality of life questionnaires and diaries. Exclusion Criteria: No Gram positive bacteria identified in the infected foot, infection with a Gram positive organism that is resistant to one of the two study drugs, or infection with coagulase negative staphylococci as the only Gram positive organism isolated. Known hypersensitivity to either of the two proposed study agents, or to ciprofloxacin, if a second anti-microbial agent is necessary. Renal dysfunction, such that the study subject requires dialysis. The presence of active osteomyelitis in the foot. The presence of concomitant infections that would require antibiotic therapy in addition to that being prescribed for the foot infection. The presence of pneumonitis requiring antimicrobial therapy, regardless of the suspected etiologic organism. A history of drug induced ototoxicity (either auditory or vestibular). A history of previous or current vascular catheter-associated phlebitis. Pregnancy or breastfeeding. Alcohol or drug use which, in the opinion of the investigator, is likely to interfere with the conduct of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Poretz, MD
Organizational Affiliation
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Alliance for Research & Education, Infectious Diseases, LlC
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Infuscience
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-economic Comparison of Daptomycin vs. Vancomycin Based Regimens

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