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

NCT ID: NCT01133600

Last Updated: 2013-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-08-31

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

1. 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

2. to compare Quality of Life and patient satisfaction among recipients of a daptomycin vs. a vancomycin based regimen

3. to compare the safety and tolerance (adverse experiences) of daptomycin vs. vancomycin based regimens

4. to compare the efficacy (complete resolution of infection) of daptomycin vs. vancomycin based regimens

Conditions

Diabetic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

daptomycin

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.

Group Type: ACTIVE_COMPARATOR

Cubicin

Intervention Type: DRUG

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.

vancomycin

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

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

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

Interventions

Cubicin

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

Vancomycin

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

Clinical Alliance for Research & Education - Infectious Diseases, LLC.

OTHER

Sponsor Role: lead

Responsible Party

Donald Poretz

Research Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald Poretz, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Alliance for Research & Education - Infectious Diseases, LLC.

Locations

Clinical Alliance for Research & Education, Infectious Diseases, LlC

Annandale, Virginia, United States

Infuscience

Annandale, Virginia, United States

Countries

United States

Other Identifiers

2008-0020-15

Identifier Type: -

Identifier Source: org_study_id