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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01199783
• Other study ID #: MCBC134ADE02T
• Status: Terminated
• Phase: Phase 3
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2023
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Drug:
• Daptomycin
Infusion (6 mg/kg/bodyweight) once daily
• Vancomycin
vancomycin once daily (effective blood-plasma concentration of 15 mg/L)

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum	Bad Oeynhausen

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	14 days
Secondary	Duration of Therapy	Duration of therapy until infection was solved in days	14 days
Secondary	Therapy Related Complications	Number of therapy related complications	within time frame of 14 days
Secondary	Number of Successful Treatments at TOC	from the clinician point of view (clinical signs and symptoms); from microbiological analysis	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	within time frame of 14 days