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

This study has been terminated.
(Patient number to be enrolled not reachable in prospected time frame, decision to stop the study prematurely was made.)
Sponsor:
Information provided by (Responsible Party):
Diethelm Tschoepe, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01199783
First received: April 29, 2010
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Diabetic Foot
Drug: Daptomycin
Drug: Vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of therapy [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    time to cure in days is required

  • Therapy related complications [ Time Frame: within time frame of 14 days ] [ Designated as safety issue: Yes ]
  • Number of successful treatments at TOC [ Time Frame: within time frame of 14 days ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199783

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

No publications provided

Responsible Party: Diethelm Tschoepe, Prof. Dr. Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01199783     History of Changes
Other Study ID Numbers: MCBC134ADE02T
Study First Received: April 29, 2010
Last Updated: March 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ruhr University of Bochum:
Diabetic Foot,MRSA,
Complicated skin and skin structure infections
Antimicrobial therapy
Daptomycin

Additional relevant MeSH terms:
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
Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014