CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Ceftolozane/tazobactam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02620774
NCT02620774Phase 1Completed
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Tissue Penetration of Ceftolozane/Tazobactam in Diabetic Patients With Lower Limb Infections

Hartford Hospital·interventional·Posted Dec 3, 2015·Updated Jan 15, 2019

In Brief

A Phase 1 clinical trial evaluating Ceftolozane/tazobactam and Microdialysis Catheter Insertion for Diabetes and 2 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Wound Infection, Healthy Volunteers
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 3, 2015
Enrollment StartFeb 19, 2016
Primary CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.6 years ago

Interventions

Ceftolozane/tazobactamdrug

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

Microdialysis Catheter Insertionprocedure

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.