NCT02620774

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will enroll 10 patients with diabetes who are admitted with a lower limb wound infection and 6 healthy volunteer control participants. The study will take place in an inpatient unit at Hartford Hospital for all patients and in the Clinical Research Center at Hartford Hospital for all healthy volunteers. All participants will receive at least 3 doses of ceftolozane/tazobactam 1.5g every 8 hours. A microdialysis probe (Mdialysis Inc., N. Chelmsford MA) will be inserted into the subcutaneous soft tissue near the margin of the wound (patients) or in the thigh (healthy volunteers). The microdialysis probe is perfused with lactated Ringer's solution and samples are collected each hour for 8 hours after the final dose. A peripheral intravenous catheter will be inserted into an arm vein to collect blood samples simultaneously with microdialysis samples. Concentrations in tissue are compared with blood to determine percent penetration.

Conditions

• Diabetes
• Wound Infection
• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-02-19
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2015-12-03
• Last updated: 2019-01-15
• Results posted: 2019-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study