A Phase 3 interventional study of Daptomycin and Vancomycin in Diabetic Foot, sponsored by Ruhr University of Bochum. Terminated at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Ruhr University of Bochum · Phase 3, Interventional, and Treatment
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 1 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Ruhr University of Bochum is the lead sponsor of 124 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Infusion of Daptomycin (6 mg/kg bodyweight) once daily
Drug: Daptomycin
Vancomycin once daily (effective blood-plasma concentration of 15 mg/l)
Drug: Vancomycin
Infusion (6 mg/kg/bodyweight) once daily
Also known as: Cubicin
vancomycin once daily (effective blood-plasma concentration of 15 mg/L)
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
Duration of Therapy
Duration of therapy until infection was solved in days
Time frame: 14 days
Therapy Related Complications
Number of therapy related complications
Time frame: within time frame of 14 days
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
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
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.
| Milestone | Daptomycin | Vancomycin |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
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
| Participants | Daptomycin | Vancomycin |
|---|---|---|
| Clinical Response of the Infection at Test-of-cure (TOC) at Day 14 Post Therapy | 1 | — |
Duration of therapy until infection was solved in days
| days | Daptomycin | Vancomycin |
|---|---|---|
| Duration of Therapy | 5 | — |
Number of therapy related complications
| number of events | Daptomycin | Vancomycin |
|---|---|---|
| Therapy Related Complications | 0 | — |
* from the clinician point of view (clinical signs and symptoms) * from microbiological analysis
| Participants | Daptomycin | Vancomycin |
|---|---|---|
| Number of Successful Treatments at TOC | 1 | — |
Rate of amputations due to infection given as number of events per total events in the study in percent
No measurements were reported for this outcome.
Collected over 14 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Daptomycin | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Vancomycin | — | — | — |
as only one patient was randomized and study was terminated prematurely, no analysis was and will be performed
| Age, Continuous(years) | Daptomycin | Vancomycin | Total |
|---|---|---|---|
| Mean | 71 ± 0 | — | 71 ± 0 |
| Sex: Female, Male(Participants) | Daptomycin | Vancomycin | Total |
|---|---|---|---|
| Female | 0 | — | 0 |
| Male | 1 | — | 1 |
| Race (NIH/OMB)(Participants) | Daptomycin | Vancomycin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 0 | — | 0 |
| White | 1 | — | 1 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 0 | — | 0 |
| Region of Enrollment(participants) | Daptomycin | Vancomycin | Total |
|---|---|---|---|
| Germany | 1 | — | 1 |
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Ruhr University of Bochum