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

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Terminated

CT.gov ID

NCT01199783

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot	Drug: Daptomycin Drug: Vancomycin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of therapy [14 days]
time to cure in days is required
Therapy related complications [within time frame of 14 days]
Number of successful treatments at TOC [within time frame of 14 days]
from the clinician point of view (clinical signs and symptoms) from microbiological analysis
Rate of amputations due to infection [within time frame of 14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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)