Soft Tissue Infection Clinical Trial
Official title:
Target Site Pharmacokinetics of Ertapenem After Multiple Doses in Diabetes Patients With Soft Tissue Infection
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.
n/a
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02099227 -
Comparative Effectiveness of Emergency Ultrasound Guided Management of Pediatric Soft Tissue Infections
|
N/A |