Clinical trial NCT01199783: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Foot
Keywords: Diabetic Foot,MRSA,
Complicated skin and skin structure infections
Antimicrobial therapy
Daptomycin
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Clinical Response of the Infection at Test-of-cure (TOC) at Day 14 Post Therapy
timeFrame: 14 days
Secondary outcomes:
measure: Duration of Therapy
timeFrame: 14 days
measure: Therapy Related Complications
timeFrame: within time frame of 14 days
measure: Number of Successful Treatments at TOC
timeFrame: within time frame of 14 days
measure: Rate of Amputations Due to Infection
timeFrame: within time frame of 14 days
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum
Study officials:
affiliation: Herz- und Diabeteszentrum NRW
name: Diethelm Tschoepe, Prof Dr Dr
role: PRINCIPAL_INVESTIGATOR
References: