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

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

February 19, 2016

Primary Completion Date

April 30, 2017

Study Completion Date

April 30, 2017

Conditions
DiabetesWound InfectionHealthy 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.

Trial Locations (1)

06102

Hartford Hospital, Hartford

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Hartford Hospital

OTHER

NCT02620774 - Tissue Penetration of Ceftolozane/Tazobactam in Diabetic Patients With Lower Limb Infections | Biotech Hunter | Biotech Hunter