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

Last updated: August 29, 2023
Sponsor: Ruhr University of Bochum
Overall Status: Terminated

Phase

3

Condition

Diabetes And Hypertension

Treatment

Vancomycin

Daptomycin

Clinical Study ID

NCT01199783
MCBC134ADE02T
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 therequirements of the study
  • Sexually active females, unless surgically sterile, must be willing to use 2 forms ofcontraception through the end of the study. Sexually active woman must, except if theywere surgically sterilized, have to use for already 30 days before first dose of studymedication an effective method of pregnancy prevention. Acceptable forms ofcontraception for female subjects include: oral, transdermal, injectable or implantedcontraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide,cervical cap, absolute waiver of sexual intercourse, use of a condom by the sexualpartner, or sterile sexual partner. Male subjects with partners of child-bearingpotential should use barrier contraception in addition to having their partners useanother method of contraception.

Exclusion

Exclusion Criteria:

  • Osteomyelitis according to international consensus guideline (3 of 5 criteria applyfor 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 30days
  • 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 mgPrednisolon-equivalents)
  • Chronic liver disease (AST or ALT increased to 10fold, bilirubin increased tothreefold compared to normal values)

Study Design

Total Participants: 1
Treatment Group(s): 2
Primary Treatment: Vancomycin
Phase: 3
Study Start date:
July 01, 2011
Estimated Completion Date:
December 31, 2013

Connect with a study center

  • Herz- und Diabeteszentrum

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

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