Diabetic FootPhase 4NCT01133600
Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-economic Comparison of Daptomycin vs. Vancomycin Based Regimens
A Phase 4 study testing Cubicin and Vancomycin in people with Diabetic Foot, run by Clinical Alliance for Research & Education - Infectious Diseases, LLC. at 2 sites in United States.
Trial summary
The purpose of the study is to evaluate the overall burden to the participant (economic, quality of life, patients satisfaction and freedom from side effects) when treating Gram positive infections of the foot in diabetic adults with daptomycin versus vancomycin. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Cubicin and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Aug 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80 who are able to give informed consent and, who are likely to be able to participate through the full 28 day of the study.
- Previously diagnosed diabetes mellitus, requiring the use of insulin and/or oral hypoglycemic agents for glycemic control.
- The presence of an infection of one or both feet (defined as being distal to the superior-most point of the lateral malleolus), with some drainage, abscess or fluid collection that can be cultured, yet which as not been treated for greater than 24 hours with prior oral antibiotic therapy within the last 48 hours, wand which does not include either a quinolone or linezolid. The foot lesion, in the opinion of the initial treating physician, is severe enough (either because of the lesion or because of the subject's diabetic control, vasculopathy, etc) to require intravenous antibiotics.
- A culture of the wound, either at the time of screening or within the 72 hours prior to screening, that yields a Gram positive organism that is shown to be sensitive (or is likely to be sensitive) to both vancomycin and daptomycin. This will include Staphylococcus aureus, (including MSSA and MRSA, but excluding VRSA), Enterococcus faecalis and enterococcus faecium (excluding VRE), streptococci, including Groups A and B, as well as other beta-hemolytic streptococci, viridans streptococci, and Group D. A culture of coagulase negative staphylococci as the only Gram positive isolate will not be considered for participation. Cultures may be obtained as swab or fluid submitted for culture.
- Able to read and write in English with a proficiency suitable for completing the pharmaco-economic and quality of life questionnaires and diaries.
Who cannot join
- No Gram positive bacteria identified in the infected foot, infection with a Gram positive organism that is resistant to one of the two study drugs, or infection with coagulase negative staphylococci as the only Gram positive organism isolated.
- Known hypersensitivity to either of the two proposed study agents, or to ciprofloxacin, if a second anti-microbial agent is necessary.
- Renal dysfunction, such that the study subject requires dialysis.
- The presence of active osteomyelitis in the foot.
- The presence of concomitant infections that would require antibiotic therapy in addition to that being prescribed for the foot infection.
- The presence of pneumonitis requiring antimicrobial therapy, regardless of the suspected etiologic organism.
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- A history of drug induced ototoxicity (either auditory or vestibular).
- A history of previous or current vascular catheter-associated phlebitis.
- Pregnancy or breastfeeding.
- Alcohol or drug use which, in the opinion of the investigator, is likely to interfere with the conduct of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Alliance for Research & Education, Infectious Diseases, LlC
Annandale, Virginia, 22003
Infuscience
Annandale, Virginia, 22003
About this study
Official title: Phase IV Study of the Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-Economic Comparison of Daptomycin vs Vancomycin Based Regimens
The purpose of the study is to evaluate the overall burden to the participant (economic, quality of life, patients satisfaction and freedom from side effects) when treating Gram positive infections of the foot in diabetic adults with daptomycin versus vancomycin.
Read the detailed description
- to compare the overall economic burden of therapy of a daptomycin vs. a vancomycin based antibiotic regimen for diabetic foot infections in the outpatient setting
- to compare Quality of Life and patient satisfaction among recipients of a daptomycin vs. a vancomycin based regimen
- to compare the safety and tolerance (adverse experiences) of daptomycin vs. vancomycin based regimens
- to compare the efficacy (complete resolution of infection) of daptomycin vs. vancomycin based regimens
- Conditions
- Diabetic Foot
- Being tested
- Cubicin, Vancomycin
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CubicinDrug
dosed at 6 mg/kg body weight intravenously every 24 hours with a reduction to 6mg/kg every other day if CrCl is <30ml/min.
VancomycinDrug
dosed at 15mg/kg intravenously every 12 hours with adjustments for renal function.
| Study group | Role | What they receive |
|---|---|---|
| daptomycin | Active comparator | Dosed at 6mg/kg body weight intravenously every 24 hours with a reduction to 6mg/kg every other day if creatinine clearance (CrCl)is <30ml/min. Receives: Drug: Cubicin |
| vancomycin | Active comparator | Dosed at 15mg/kg intravenously every 12 hours with adjustments for renal function. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmaco-economic
Based upon 2 economic parameters associated with the treatment of the infection (provider charges and out-of-pocket costs) from screening until Day 28. Provider charges, as documented in invoices submitted to the pt's. insurance company, will be collected for all activities and services provided by the physician's office,home infusion company, laboratory, etc. during the study period. Out of pocket costs will be captured in a pt. diary and will include any health related costs that are borne by the pt. during the study period. Costs and charges will be analyzed and reported separately.
Measured: 28 days
Secondary outcomes (1)
Quality of Life/patient satisfaction
QOL and pt. satisfaction with the medication, the clinical care, and the overall experience of the infection and its therapy are captured using three study intstruments, which are described in more detail in the Data Collection Instruments section. These include two validated, standardized QOL instruments administred at Baseline, at two weeks and again at 4 weeks, and a pt. satisfaction survey administered at Baseline, 2 and 4 weeks.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Lack of patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Alliance for Research & Education - Infectious Diseases, LLC.
- Sponsor type
- University, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Principal investigator, Donald Poretz, Clinical Alliance for Research & Education - Infectious Diseases, LLC.
- Investigators
- Donald Poretz, MD, Principal investigator, Clinical Alliance for Research & Education - Infectious Diseases, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133600
- Sponsor's protocol ID
- 2008-0020-15
- Status last verified
- Sep 2013
- First submitted
- 28 May 2010
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of the Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-Economic Comparison of Daptomycin vs Vancomycin Based Regimens
- ClinicalTrials.gov ID
- NCT01133600
- Acronym / sponsor ID
- 2008-0020-15
- Conditions
- Diabetic Foot
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Clinical Alliance for Research & Education - Infectious Diseases, LLC.University, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the overall burden to the participant (economic, quality of life, patients satisfaction and freedom from side effects) when treating Gram positive infections of the foot in diabetic adults with daptomycin versus vancomycin.
Detailed description
- to compare the overall economic burden of therapy of a daptomycin vs. a vancomycin based antibiotic regimen for diabetic foot infections in the outpatient setting
- to compare Quality of Life and patient satisfaction among recipients of a daptomycin vs. a vancomycin based regimen
- to compare the safety and tolerance (adverse experiences) of daptomycin vs. vancomycin based regimens
- to compare the efficacy (complete resolution of infection) of daptomycin vs. vancomycin based regimens
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| daptomycin | Active comparator | Drug: CubicinDosed at 6mg/kg body weight intravenously every 24 hours with a reduction to 6mg/kg every other day if creatinine clearance (CrCl)is <30ml/min. |
| vancomycin | Active comparator | Drug: VancomycinDosed at 15mg/kg intravenously every 12 hours with adjustments for renal function. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 who are able to give informed consent and, who are likely to be able to participate through the full 28 day of the study.
- Previously diagnosed diabetes mellitus, requiring the use of insulin and/or oral hypoglycemic agents for glycemic control.
- The presence of an infection of one or both feet (defined as being distal to the superior-most point of the lateral malleolus), with some drainage, abscess or fluid collection that can be cultured, yet which as not been treated for greater than 24 hours with prior oral antibiotic therapy within the last 48 hours, wand which does not include either a quinolone or linezolid. The foot lesion, in the opinion of the initial treating physician, is severe enough (either because of the lesion or because of the subject's diabetic control, vasculopathy, etc) to require intravenous antibiotics.
- A culture of the wound, either at the time of screening or within the 72 hours prior to screening, that yields a Gram positive organism that is shown to be sensitive (or is likely to be sensitive) to both vancomycin and daptomycin. This will include Staphylococcus aureus, (including MSSA and MRSA, but excluding VRSA), Enterococcus faecalis and enterococcus faecium (excluding VRE), streptococci, including Groups A and B, as well as other beta-hemolytic streptococci, viridans streptococci, and Group D. A culture of coagulase negative staphylococci as the only Gram positive isolate will not be considered for participation. Cultures may be obtained as swab or fluid submitted for culture.
- Able to read and write in English with a proficiency suitable for completing the pharmaco-economic and quality of life questionnaires and diaries.
Key exclusion criteria (10 listed)
- No Gram positive bacteria identified in the infected foot, infection with a Gram positive organism that is resistant to one of the two study drugs, or infection with coagulase negative staphylococci as the only Gram positive organism isolated.
- Known hypersensitivity to either of the two proposed study agents, or to ciprofloxacin, if a second anti-microbial agent is necessary.
- Renal dysfunction, such that the study subject requires dialysis.
- The presence of active osteomyelitis in the foot.
- The presence of concomitant infections that would require antibiotic therapy in addition to that being prescribed for the foot infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cubicindosed at 6 mg/kg body weight intravenously every 24 hours with a reduction to 6mg/kg every other day if CrCl is <30ml/min. | Drug | daptomycin |
| Vancomycindosed at 15mg/kg intravenously every 12 hours with adjustments for renal function. | Drug | vancomycin |
Primary outcome
Pharmaco-economic
Time frame: 28 days
Based upon 2 economic parameters associated with the treatment of the infection (provider charges and out-of-pocket costs) from screening until Day 28. Provider charges, as documented in invoices submitted to the pt's. insurance company, will be collected for all activities and services provided by the physician's office,home infusion company, laboratory, etc. during the study period. Out of pocket costs will be captured in a pt. diary and will include any health related costs that are borne by the pt. during the study period. Costs and charges will be analyzed and reported separately.
1 secondary outcome
Quality of Life/patient satisfaction
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Lack of patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Poretz, MD principal investigator
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cubicin and Vancomycin in people with Diabetic Foot, run by Clinical Alliance for Research & Education - Infectious Diseases, LLC. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of patient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmaco-economic (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.