Diabetic FootPhase 3NCT01199783

Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment

A Phase 3 study testing Daptomycin and Vancomycin in people with Diabetic Foot, run by Ruhr University of Bochum at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetic Foot
What is being tested?: Daptomycin and Vancomycin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteGermany
Study dates: Jul 2011to Dec 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 11Show fewer

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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

Herz- und Diabeteszentrum
Bad Oeynhausen, 32545

Other trials in Germany

About this study

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.

Conditions: Diabetic Foot
Being tested: Daptomycin, Vancomycin
Keywords: Diabetic Foot,MRSA,, Complicated skin and skin structure infections, Antimicrobial therapy, Daptomycin
Medical subject headings: Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DaptomycinDrug
Also called Cubicin
Infusion (6 mg/kg/bodyweight) once daily
VancomycinDrug
vancomycin once daily (effective blood-plasma concentration of 15 mg/L)

Study groups in NCT01199783
Study group	Role	What they receive
Daptomycin	Experimental	Infusion of Daptomycin (6 mg/kg bodyweight) once daily Receives: Drug: Daptomycin
Vancomycin	Active comparator	Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) Receives: Drug: Vancomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 14 days

Secondary outcomes (4)

Duration of Therapy
Duration of therapy until infection was solved in days
Measured: 14 days
Therapy Related Complications
Number of therapy related complications
Measured: 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
Measured: 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
Measured: within time frame of 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Dec 2013

First posted13 Sep 2010 (estimated)
Study startJul 2011
Primary completionOct 2013
Study completionDec 2013

Why it stopped: Patient number to be enrolled not reachable in prospected time frame, decision to stop the study prematurely was made.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01199783
Sponsor's protocol ID: MCBC134ADE02T
Status last verified: Aug 2023
First submitted: 29 Apr 2010
Last updated: 18 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Diabetic Foot trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment
ClinicalTrials.gov ID: NCT01199783
Acronym / sponsor ID: MCBC134ADE02T
Conditions: Diabetic Foot
Keywords: Diabetic Foot,MRSA,, Complicated skin and skin structure infections, Antimicrobial therapy, Daptomycin
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Patient number to be enrolled not reachable in prospected time frame, decision to stop the study prematurely was made.
Enrolment: 1 participants (actual)
Lead sponsor: Ruhr University of BochumUniversity, hospital or other
Study start: Jul 2011
Primary completion: Oct 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 13 Sep 2010 (estimated)
Results: Posted 18 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Daptomycin	Experimental	Drug: DaptomycinInfusion of Daptomycin (6 mg/kg bodyweight) once daily
Vancomycin	Active comparator	Drug: VancomycinVancomycin once daily (effective blood-plasma concentration of 15 mg/l)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (11 listed)

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

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
DaptomycinAlso: CubicinInfusion (6 mg/kg/bodyweight) once daily	Drug	Daptomycin
Vancomycinvancomycin once daily (effective blood-plasma concentration of 15 mg/L)	Drug	Vancomycin

Primary outcome

Clinical Response of the Infection at Test-of-cure (TOC) at Day 14 Post Therapy
Time frame: 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

4 secondary outcomes

Duration of Therapy
Time frame: 14 days
Therapy Related Complications
Time frame: within time frame of 14 days
Number of Successful Treatments at TOC
Time frame: within time frame of 14 days
Rate of Amputations Due to Infection
Time frame: within time frame of 14 days

Results and safety

Results posted to the registry on 18 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Daptomycin	1	1
Vancomycin	0	0

Primary outcome: Clinical Response of the Infection at Test-of-cure (TOC) at Day 14 Post Therapy

Time frame: 14 days. Count of participants. Unit: Participants

Measure	Daptomycin n = 1	Vancomycin n = 0
Value	1	–

Population analysed: Participant's infection was solved at day 5 of the study - only 1 participant was treated in the study

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daptomycin	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Vancomycin	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Foot

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

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.

Diethelm Tschoepe, Prof Dr Dr principal investigator

Herz- und Diabeteszentrum NRW

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daptomycin and Vancomycin in people with Diabetic Foot, run by Ruhr University of Bochum at 1 site in Germany.

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 7 inclusion and 11 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 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Response of the Infection at Test-of-cure (TOC) at Day 14 Post Therapy (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01199783.

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 18 Mar 2024.