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Tissue Penetration of Ceftolozane/Tazobactam in Diabetic Patients With Lower Limb Infections

NCT02620774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-01-15

Study results available
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Summary

This study will determine the tissue penetration of ceftolozane/tazobactam (Zerbaxa, Merck \& Co.), a novel β-lactam/β-lactamase combination antibiotic, into the extracellular, interstitial fluid of soft tissue in diabetic patients with lower limb wound infections. Penetration will be compared with a group of healthy volunteer control participants.

Conditions

  • Diabetes
  • Wound Infection
  • Healthy Volunteers

Interventions

DRUG

Ceftolozane/tazobactam

3 or more doses of ceftolozane/tazobactam intravenously administered over 60 minutes every 8 hours

PROCEDURE

Microdialysis Catheter Insertion

A 20 kila-Dalton microdialysis probe (63 MD catheter; MDialysis Inc., N. Chelmsford, MA) will be inserted into the subcutaneous tissue at the margin of the wound (patient group) or in the thigh tissue (healthy volunteers). The probe will be left in place for the final dose and all tissue sampling procedures thereafter. This probe is perfused with a physiologic solution to collect interstitial fluid samples. The probe will then be removed after completion of sample collection.

Sponsors & Collaborators

Principal Investigators

  • David P Nicolau, PharmD · Harford Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-19
Primary Completion
2017-04-30
Completion
2017-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02620774 on ClinicalTrials.gov