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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Diethelm Tschoepe, Ruhr University of Bochum

Tracking Information
First Submitted Date  ICMJE April 29, 2010
First Posted Date  ICMJE September 13, 2010
Last Update Posted Date May 5, 2015
Study Start Date  ICMJE July 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2010)
Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01199783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2010)
  • Duration of therapy [ Time Frame: 14 days ]
    time to cure in days is required
  • Therapy related complications [ Time Frame: within time frame of 14 days ]
  • 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
  • Rate of amputations due to infection [ Time Frame: within time frame of 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment
Official Title  ICMJE Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot
Intervention  ICMJE
  • Drug: Daptomycin
    Infusion (6 mg/kg/bodyweight) once daily
    Other Name: Cubicin
  • Drug: Vancomycin
    vancomycin once daily (effective blood-plasma concentration of 15 mg/L)
Study Arms  ICMJE
  • Experimental: Daptomycin
    Infusion of Daptomycin (6 mg/kg bodyweight) once daily
    Intervention: Drug: Daptomycin
  • Active Comparator: Vancomycin
    Vancomycin once daily (effective blood-plasma concentration of 15 mg/l)
    Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 26, 2012)
1
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2010)
120
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01199783
Other Study ID Numbers  ICMJE MCBC134ADE02T
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Diethelm Tschoepe, Ruhr University of Bochum
Study Sponsor  ICMJE Ruhr University of Bochum
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Diethelm Tschoepe, Prof Dr Dr Herz- und Diabeteszentrum NRW
PRS Account Ruhr University of Bochum
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP