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Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199783
Recruitment Status : Terminated (Patient number to be enrolled not reachable in prospected time frame, decision to stop the study prematurely was made.)
First Posted : September 13, 2010
Last Update Posted : May 5, 2015
Information provided by (Responsible Party):
Diethelm Tschoepe, Ruhr University of Bochum

Brief Summary:
Objective of the study is to test whether Daptomycin (6 mg/kg bodyweight) is non-inferior in treatment of severe diabetic foot infections (MRSA) in comparison to antibiotic treatment with Vancomycin (effective blood-plasma concentration of 15 mg/l). In case of microbiologically confirmed gram-negative co-infection effective antibiotic treatment according to microbiologic analysis will be administered upon medical decision in both therapy groups. The study will be carried out as a randomized, open label study.

Condition or disease Intervention/treatment Phase
Diabetic Foot Drug: Daptomycin Drug: Vancomycin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment
Study Start Date : July 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Daptomycin
Infusion of Daptomycin (6 mg/kg bodyweight) once daily
Drug: Daptomycin
Infusion (6 mg/kg/bodyweight) once daily
Other Name: Cubicin

Active Comparator: Vancomycin
Vancomycin once daily (effective blood-plasma concentration of 15 mg/l)
Drug: Vancomycin
vancomycin once daily (effective blood-plasma concentration of 15 mg/L)

Primary Outcome Measures :
  1. Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Duration of therapy [ Time Frame: 14 days ]
    time to cure in days is required

  2. Therapy related complications [ Time Frame: within time frame of 14 days ]
  3. Number of successful treatments at TOC [ Time Frame: within time frame of 14 days ]
    • from the clinician point of view (clinical signs and symptoms)
    • from microbiological analysis

  4. Rate of amputations due to infection [ Time Frame: within time frame of 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 1 and Type 2 Diabetes mellitus
  • MRSA infected foot ulcus Wagner 1-2 without primary surgical intervention
  • Therapy duration will last at least more than 5 days
  • men and women age 18 - 80 years
  • Declaration of patient's consent
  • Ability and willingness to give written informed consent and to comply with the requirements of the study
  • Sexually active females, unless surgically sterile, must be willing to use 2 forms of contraception through the end of the study. Sexually active woman must, except if they were surgically sterilized, have to use for already 30 days before first dose of study medication an effective method of pregnancy prevention. Acceptable forms of contraception for female subjects include: oral, transdermal, injectable or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, absolute waiver of sexual intercourse, use of a condom by the sexual partner, or sterile sexual partner. Male subjects with partners of child-bearing potential should use barrier contraception in addition to having their partners use another method of contraception.

Exclusion Criteria:

  • Osteomyelitis according to international consensus guideline (3 of 5 criteria apply for diagnosis)
  • Presence of a severe nephropathy (creatinine clearance < 30 ml/min)
  • Advanced diabetic retinopathy
  • Simultaneous participation in another study or participation in a study in the past 30 days
  • Non permissible concomitant medication e.g. therapy regimen using several antibiotics
  • Contraindication for antibiotics
  • Dialysis essential
  • Pregnancy (to be determined by pregnancy test) or unsafe contraception
  • Neutropenia
  • immunosuppression (oral immunosuppressives, Corticoids exaggerating 7.5 mg Prednisolon-equivalents)
  • Chronic liver disease (AST or ALT increased to 10fold, bilirubin increased to threefold compared to normal values)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01199783

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Herz- und Diabeteszentrum
Bad Oeynhausen, Germany, 32545
Sponsors and Collaborators
Ruhr University of Bochum
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Principal Investigator: Diethelm Tschoepe, Prof Dr Dr Herz- und Diabeteszentrum NRW

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Responsible Party: Diethelm Tschoepe, Prof. Dr. Dr., Ruhr University of Bochum Identifier: NCT01199783    
Other Study ID Numbers: MCBC134ADE02T
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: March 2012
Keywords provided by Diethelm Tschoepe, Ruhr University of Bochum:
Diabetic Foot,MRSA,
Complicated skin and skin structure infections
Antimicrobial therapy
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Anti-Bacterial Agents
Anti-Infective Agents