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Target Site Pharmacokinetics of Ertapenem After Multiple Doses in Diabetes Patients With Soft Tissue Infection (2007-005020-33)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658866
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : August 9, 2011
Information provided by:
Medical University of Vienna

Brief Summary:

Background/rationale: Ertapenem is an innovative antimicrobial agent, which is approved in the European Union for diabetic foot infections of the skin and soft tissue. Although its antimicrobial spectrum and activity against ESBL-strains are promising to treat infected ulcers associated with diabetes, there is a lack of data on tissue pharmacokinetics of ertapenem in this patient population. However, for antimicrobial efficacy it is important to show that the antibiotic achieves sufficient concentrations at the site of infection, i.e. in tissue. A recent clinical study by Burkhardt et al. (Journal of Antimicrobial Chemotherapy, 2006) using the microdialysis technique showed that the free tissue concentrations after a single dose of 1 g ertapenem are sufficient and adequate to kill most relevant bacteria, suggesting efficacy of ertapenem for soft tissue infections. It is well known that there is no accumulation of ertapenem in plasma after multiple doses of 1 g every 24 h in patients without significantly impaired renal function. The single dose study by Burkhardt et al. also suggests that only negligible drug accumulation can be expected in soft tissues of healthy young volunteers after multiple doses. However, it was shown for other antibiotics that tissue PK may be significantly different under pathologic conditions, leading to impaired penetration, but subsequent accumulation after multiple doses due to a longer tissue half life than in healthy volunteers. Since the properties of inflamed tissue may diverge from those of healthy tissue it is important to evaluate which concentrations of ertapenem are reached in inflamed tissue after multiple doses.

Clinical study: In the present study we will measure the concentrations of ertapenem over time in plasma and infected tissue of 10 diabetes patients after multiple doses. The microdialysis technique will be used. The ertapenem concentrations will be measured in inflamed tissue and in non-inflamed subcutaneous tissue to identify the effect of inflammation on pharmacokinetics. The findings of the present study will help to confirm the efficacy of ertapenem for the indication of diabetic soft tissue infections.

Condition or disease Intervention/treatment Phase
Soft Tissue Infection Procedure: Microdialysis Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Target Site Pharmacokinetics of Ertapenem After Multiple Doses in Diabetes Patients With Soft Tissue Infection
Study Start Date : February 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Microdialysis
    PK measurements with microdialysis

Primary Outcome Measures :
  1. Pharmacokinetics in tissue [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, aged between 18 and 85 years
  • Diagnosis of Diabetes mellitus
  • Clinically diagnosed skin or soft tissue infection and/or infected ulcers of the leg, requiring antimicrobial therapy
  • Prescription of ertapenem for therapeutic reasons
  • Willingness and ability to comply with the protocol
  • Signed informed consent

Exclusion Criteria:

  • HIV, Hepatitis B or C positive
  • Allergy or hypersensitivity against study drug
  • Severe renal impairment, defined by a serum creatinine level > 1.6 mg/L
  • Pregnancy, or women of child bearing potential not willing to apply adequate contraception during study period
  • Any disease considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00658866

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Medical University Vienna, Department of Clinical Pharacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Markus Mueller, MD Medical University of Vienna, Dep. of Clinical Pharmacology
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Responsible Party: Markus Mueller, Medical University of Vienna, Department of Clinical Pharmacology Identifier: NCT00658866    
Other Study ID Numbers: Erta_MD_1
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: March 2011
Keywords provided by Medical University of Vienna:
ertapenem tissue PK
Additional relevant MeSH terms:
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Communicable Diseases
Soft Tissue Infections