Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment
This study has been terminated.
(Patient number to be enrolled not reachable in prospected time frame, decision to stop the study prematurely was made.)
Sponsor:
Ruhr University of Bochum
Information provided by (Responsible Party):
Diethelm Tschoepe, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01199783
First received: April 29, 2010
Last updated: March 26, 2012
Last verified: March 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diabetic Foot |
Drug: Daptomycin Drug: Vancomycin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment |
Resource links provided by NLM:
Further study details as provided by Ruhr University of Bochum:
Primary Outcome Measures:
- Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of therapy [ Time Frame: 14 days ] [ Designated as safety issue: No ]time to cure in days is required
- Therapy related complications [ Time Frame: within time frame of 14 days ] [ Designated as safety issue: Yes ]
- Number of successful treatments at TOC [ Time Frame: within time frame of 14 days ] [ Designated as safety issue: No ]
- from the clinician point of view (clinical signs and symptoms)
- from microbiological analysis
- Rate of amputations due to infection [ Time Frame: within time frame of 14 days ] [ Designated as safety issue: No ]
| Enrollment: | 1 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Daptomycin
Infusion of Daptomycin (6 mg/kg bodyweight) once daily
|
Drug: Daptomycin
Infusion (6 mg/kg/bodyweight) once daily
Other Name: 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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199783
Locations
| Germany | |
| Herz- und Diabeteszentrum | |
| Bad Oeynhausen, Germany, 32545 | |
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
| Principal Investigator: | Diethelm Tschoepe, Prof Dr Dr | Herz- und Diabeteszentrum NRW |
More Information
No publications provided
| Responsible Party: | Diethelm Tschoepe, Prof. Dr. Dr., Ruhr University of Bochum |
| ClinicalTrials.gov Identifier: | NCT01199783 History of Changes |
| Other Study ID Numbers: | MCBC134ADE02T |
| Study First Received: | April 29, 2010 |
| Last Updated: | March 26, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Ruhr University of Bochum:
|
Diabetic Foot,MRSA, Complicated skin and skin structure infections Antimicrobial therapy Daptomycin |
Additional relevant MeSH terms:
|
Diabetic Foot Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Foot Ulcer Leg Ulcer Skin Ulcer Skin Diseases Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Vancomycin Daptomycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013