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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetic Foot
• Intervention / Treatment: Drug: Daptomycin; Drug: Vancomycin

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daptomycin; Infusion of Daptomycin (6 mg/kg bodyweight) once daily	Drug: Daptomycin; Infusion (6 mg/kg/bodyweight) once daily; Other Names: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response of the Infection at Test-of-cure (TOC) at Day 14 Post Therapy	Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy by doctoral's decision For each of the patients included in the study the clinical outcome at TOC should be assessed using the following criteria: Cure: resolution of all clinical signs and symptoms of infection and a healing wound after ≥ 5 days of therapy Improvement: resolution of ≥ 2 - but not all- clinical signs and symptoms of infection after ≥ 5 days of therapy (only used at the end of therapy) Failure: persistence or progression of baseline clinical signs and symptoms of infections after ≥ 2 days of therapy Missing: patients received therapy for less than 2 days Indeterminate: circumstances preclude classification Duration of Treatment The duration of treatment will be evaluated as the number of inpatient and outpatient days the patient received antibiotic therapy, even if non-consecutive. Time to Clinical Improvement If according to the patient record	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Therapy	Duration of therapy until infection was solved in days	14 days
Therapy Related Complications	Number of therapy related complications	within time frame of 14 days
Number of Successful Treatments at TOC	from the clinician point of view (clinical signs and symptoms); from microbiological analysis	within time frame of 14 days
Rate of Amputations Due to Infection	Rate of amputations due to infection given as number of events per total events in the study in percent	within time frame of 14 days

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Investigators: Principal Investigator: Diethelm Tschoepe, Prof Dr Dr, Herz- und Diabeteszentrum NRW

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: September 10, 2010
• First Posted (Estimated): September 13, 2010

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Complicated skin and skin structure infections; Antimicrobial therapy; Daptomycin; Diabetic Foot,MRSA,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin; Daptomycin
• Other Study ID Numbers: MCBC134ADE02T