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

NCT01199783 | Terminated Phase 3 Results

• 1 other identifier: MCBC134ADE02T
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

Diabetic Foot,MRSA,; Complicated skin and skin structure infections; Antimicrobial therapy; Daptomycin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Duration of Therapy

  14 days

• Therapy Related Complications

  within time frame of 14 days

• Number of Successful Treatments at TOC

  within time frame of 14 days

• Rate of Amputations Due to Infection

  within time frame of 14 days

Study Arms (2)

Daptomycin

EXPERIMENTAL

Infusion of Daptomycin (6 mg/kg bodyweight) once daily

Drug: Daptomycin

Vancomycin

ACTIVE COMPARATOR

Vancomycin once daily (effective blood-plasma concentration of 15 mg/l)

Drug: Vancomycin

Interventions

Daptomycin DRUG

Infusion (6 mg/kg/bodyweight) once daily

Also known as: Cubicin

Daptomycin

Vancomycin DRUG

vancomycin once daily (effective blood-plasma concentration of 15 mg/L)

Vancomycin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Herz- und Diabeteszentrum

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Daptomycin; Vancomycin

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Glycopeptides; Glycoconjugates; Carbohydrates

Limitations and Caveats

recruitment of patients turned out to be limiting in a way that in due time the study could not be performed - therefore the decision to stop the trial was made

Results Point of Contact

• Title: PD Dr. Bernd Stratmann
• Organization: Herz- und Diabeteszentrum NRW

bstratmann@hdz-nrw.de

+495731973768

Study Officials

• Diethelm Tschoepe, Prof Dr Dr

  Herz- und Diabeteszentrum NRW

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: September 13, 2010
• Study Start: July 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2023-08

Locations

DE (1)