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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

Information source: Clinical Alliance for Research & Education - Infectious Diseases, LLC.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Foot

Intervention: Cubicin (Drug); Vancomycin (Drug)

Phase: Phase 4

Status: Terminated

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

Official(s) and/or principal investigator(s):
Donald Poretz, MD, Principal Investigator, Affiliation: Clinical Alliance for Research & Education - Infectious Diseases, LLC.

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pharmaco-economic

Secondary outcome: Quality of Life/patient satisfaction

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

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Clinical Alliance for Research & Education, Infectious Diseases, LlC, Annandale, Virginia 22003, United States

Infuscience, Annandale, Virginia 22003, United States

Additional Information

Starting date: August 2010
Last updated: September 9, 2013

Page last updated: August 23, 2015

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