Back to results

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

Primary Purpose

Diabetic Foot

Status

Terminated

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Daptomycin

Vancomycin

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetic Foot,MRSA,, Complicated skin and skin structure infections, Antimicrobial therapy, Daptomycin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Herz- und Diabeteszentrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daptomycin

Vancomycin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy

Secondary Outcome Measures

Duration of therapy

time to cure in days is required

Therapy related complications

Number of successful treatments at TOC

from the clinician point of view (clinical signs and symptoms) from microbiological analysis

Rate of amputations due to infection

Full Information

NCT ID

NCT01199783

First Posted

April 29, 2010

Last Updated

May 4, 2015

Sponsor

Ruhr University of Bochum

1. Study Identification

Unique Protocol Identification Number

NCT01199783

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Terminated

Why Stopped

Patient number to be enrolled not reachable in prospected time frame, decision to stop the study prematurely was made.

Study Start Date

July 2011 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruhr University of Bochum

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daptomycin

Arm Type

Experimental

Arm Description

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

Arm Title

Vancomycin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Daptomycin

Other Intervention Name(s)

Cubicin

Intervention Description

Infusion (6 mg/kg/bodyweight) once daily

Intervention Type

Drug

Intervention Name(s)

Vancomycin

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Duration of therapy

Description

time to cure in days is required

Time Frame

14 days

Title

Therapy related complications

Time Frame

within time frame of 14 days

Title

Number of successful treatments at TOC

Description

from the clinician point of view (clinical signs and symptoms) from microbiological analysis

Time Frame

within time frame of 14 days

Title

Rate of amputations due to infection

Time Frame

within time frame of 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diethelm Tschoepe, Prof Dr Dr

Organizational Affiliation

Herz- und Diabeteszentrum NRW

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herz- und Diabeteszentrum

City

Bad Oeynhausen

ZIP/Postal Code

32545

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs