Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

February 10, 2020

Primary Completion Date

July 12, 2021

Study Completion Date

July 29, 2021

Conditions
DiabetesWound InfectionHealthy Volunteers
Interventions
DRUG

Omadacycline

Omadacycline will be administered 200 mg IV once daily on day 1 followed by omadacycline 300 mg by mouth once daily for 2-4 doses.

PROCEDURE

Microdialysis Catheter Insertion

A 20 kilodalton 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

Sponsors
All Listed Sponsors
collaborator

Paratek Pharmaceuticals Inc

INDUSTRY

lead

Hartford Hospital

OTHER