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

NCT ID: NCT01199783

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Daptomycin

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

Group Type: EXPERIMENTAL

Daptomycin

Intervention Type: DRUG

Infusion (6 mg/kg/bodyweight) once daily

Vancomycin

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

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

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

Interventions

Daptomycin

Infusion (6 mg/kg/bodyweight) once daily

Intervention Type: DRUG

Vancomycin

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

Intervention Type: DRUG

Other Intervention Names

Cubicin

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Diethelm Tschoepe

Prof. Dr. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diethelm Tschoepe, Prof Dr Dr

Role: PRINCIPAL_INVESTIGATOR

Herz- und Diabeteszentrum NRW

Locations

Herz- und Diabeteszentrum

Bad Oeynhausen, , Germany

Countries

Germany

Other Identifiers

MCBC134ADE02T

Identifier Type: -

Identifier Source: org_study_id