Diabetic Foot
Conditions
Keywords
Diabetic Foot,MRSA,, Complicated skin and skin structure infections, Antimicrobial therapy, Daptomycin
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.
Interventions
DRUGDaptomycin
Infusion (6 mg/kg/bodyweight) once daily
DRUGVancomycin
vancomycin once daily (effective blood-plasma concentration of 15 mg/L)
Sponsors
Ruhr University of Bochum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response of the Infection at Test-of-cure (TOC) at Day 14 Post Therapy | 14 days | Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy by doctoral's decision For each of the patients included in the study the clinical outcome at TOC should be assessed using the following criteria: Cure: resolution of all clinical signs and symptoms of infection and a healing wound after ≥ 5 days of therapy Improvement: resolution of ≥ 2 - but not all- clinical signs and symptoms of infection after ≥ 5 days of therapy (only used at the end of therapy) Failure: persistence or progression of baseline clinical signs and symptoms of infections after ≥ 2 days of therapy Missing: patients received therapy for less than 2 days Indeterminate: circumstances preclude classification Duration of Treatment The duration of treatment will be evaluated as the number of inpatient and outpatient days the patient received antibiotic therapy, even if non-consecutive. Time to Clinical Improvement If according to the patient record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Therapy | 14 days | Duration of therapy until infection was solved in days |
| Therapy Related Complications | within time frame of 14 days | Number of therapy related complications |
| 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 | Rate of amputations due to infection given as number of events per total events in the study in percent |
Countries
Germany
Participant flow
Recruitment details
Trial was prematurely stopped after inclusion of 1 patient who was randomized to the Daptomycin arm. During the trial it became obvious that the patient number to be enrolled is not reachable in prospected time frame, thus, the decision to stop the study prematurely was made.
Participants by arm
| Arm | Count |
|---|---|
| Daptomycin Infusion of Daptomycin (6 mg/kg bodyweight) once daily | 1 |
| Vancomycin Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Daptomycin | Total |
|---|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 0 | 71 years STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment Germany | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Clinical Response of the Infection at Test-of-cure (TOC) at Day 14 Post Therapy
Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy by doctoral's decision For each of the patients included in the study the clinical outcome at TOC should be assessed using the following criteria: Cure: resolution of all clinical signs and symptoms of infection and a healing wound after ≥ 5 days of therapy Improvement: resolution of ≥ 2 - but not all- clinical signs and symptoms of infection after ≥ 5 days of therapy (only used at the end of therapy) Failure: persistence or progression of baseline clinical signs and symptoms of infections after ≥ 2 days of therapy Missing: patients received therapy for less than 2 days Indeterminate: circumstances preclude classification Duration of Treatment The duration of treatment will be evaluated as the number of inpatient and outpatient days the patient received antibiotic therapy, even if non-consecutive. Time to Clinical Improvement If according to the patient record
Time frame: 14 days
Population: Participant's infection was solved at day 5 of the study - only 1 participant was treated in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daptomycin | Clinical Response of the Infection at Test-of-cure (TOC) at Day 14 Post Therapy | 1 Participants |
Secondary
Duration of Therapy
Duration of therapy until infection was solved in days
Time frame: 14 days
Population: only one participant was randomized and analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daptomycin | Duration of Therapy | 5 days |
Secondary
Number of Successful Treatments at TOC
* from the clinician point of view (clinical signs and symptoms) * from microbiological analysis
Time frame: within time frame of 14 days
Population: only one participant was randomized and analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Daptomycin | Number of Successful Treatments at TOC | 1 Participants |
Secondary
Rate of Amputations Due to Infection
Rate of amputations due to infection given as number of events per total events in the study in percent
Time frame: within time frame of 14 days
Population: only one participant was randomized and analyzed, no amputation occured
Secondary
Therapy Related Complications
Number of therapy related complications
Time frame: within time frame of 14 days
Population: only one randomized particpant available for evaluation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daptomycin | Therapy Related Complications | 0 number of events |