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Patient number to be enrolled not reachable in prospected time frame, decision to stop the study prematurely was made.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daptomycin | Experimental | Infusion of Daptomycin (6 mg/kg bodyweight) once daily |
|
| Vancomycin | Active Comparator | Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin | Drug | Infusion (6 mg/kg/bodyweight) once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Therapy | Duration of therapy until infection was solved in days | 14 days |
| Therapy Related Complications | Number of therapy related complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diethelm Tschoepe, Prof Dr Dr | Herz- und Diabeteszentrum NRW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz- und Diabeteszentrum | Bad Oeynhausen | 32545 | Germany |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daptomycin | Infusion of Daptomycin (6 mg/kg bodyweight) once daily |
| FG001 | Vancomycin | Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
as only one patient was randomized and study was terminated prematurely, no analysis was and will be performed
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| ID | Title | Description |
|---|---|---|
| BG000 | Daptomycin | Infusion of Daptomycin (6 mg/kg bodyweight) once daily |
| BG001 | Vancomycin | Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Participant's infection was solved at day 5 of the study - only 1 participant was treated in the study | Posted | Count of Participants | Participants | 14 days |
14 days
only one participant was reandomized to Daptomycin treatment and analyzed, no patients in the comparator group
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daptomycin | Infusion of Daptomycin (6 mg/kg bodyweight) once daily Daptomycin: Infusion (6 mg/kg/bodyweight) once daily |
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recruitment of patients turned out to be limiting in a way that in due time the study could not be performed - therefore the decision to stop the trial was made
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PD Dr. Bernd Stratmann | Herz- und Diabeteszentrum NRW | +495731973768 | bstratmann@hdz-nrw.de |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
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| Vancomycin | Drug | vancomycin once daily (effective blood-plasma concentration of 15 mg/L) |
|
| within time frame of 14 days |
| Number of Successful Treatments at TOC |
| 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 | within time frame of 14 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Daptomycin | Infusion of Daptomycin (6 mg/kg bodyweight) once daily Daptomycin: Infusion (6 mg/kg/bodyweight) once daily |
| OG001 | Vancomycin | Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) Vancomycin: vancomycin once daily (effective blood-plasma concentration of 15 mg/L) |
|
|
| Secondary | Duration of Therapy | Duration of therapy until infection was solved in days | only one participant was randomized and analyzed | Posted | Number | days | 14 days |
|
|
|
| Secondary | Therapy Related Complications | Number of therapy related complications | only one randomized particpant available for evaluation | Posted | Number | number of events | within time frame of 14 days |
|
|
|
| Secondary | Number of Successful Treatments at TOC |
| only one participant was randomized and analyzed | Posted | Count of Participants | Participants | within time frame of 14 days |
|
|
|
| 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 | only one participant was randomized and analyzed, no amputation occured | Posted | within time frame of 14 days | number of amputations | number of amputations |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Vancomycin | Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) Vancomycin: vancomycin once daily (effective blood-plasma concentration of 15 mg/L) | 0 | 0 | 0 | 0 | 0 | 0 |
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D008055 |
| Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |