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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01133600
• Date of registration: 28/05/2010
• Primary sponsor: Clinical Alliance for Research & Education - Infectious Diseases, LLC.
• Public title: Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-economic Comparison of Daptomycin vs. Vancomycin Based Regimens
• Scientific 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
• Date of first enrolment: August 2010
• Target sample size: 80
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01133600
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Donald Poretz, MD
• Affiliation: Clinical Alliance for Research & Education - Infectious Diseases, LLC.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Foot

Intervention(s)

Drug: Cubicin

Drug: Vancomycin

Primary Outcome(s)

Pharmaco-economic [Time Frame: 28 days]

Secondary Outcome(s)

Quality of Life/patient satisfaction [Time Frame: 28 days]

Secondary ID(s)

2008-0020-15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cubist Pharmaceuticals