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

NCT02620787 | Completed Phase 1 Results FDA Drug

• 1 other identifier: Nicolau-53466
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the tissue penetration of tedizolid (Sivextro, Merck \& Co.), a novel oxazolidinone 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

Outcome Measures

Primary Outcomes (1)

• Tedizolid Tissue Penetration

  The ratio of tedizolid tissue concentrations to blood concentrations following the final tedizolid dose

  48-72 hours

Secondary Outcomes (2)

• Tedizolid Area Under the Curve (AUC) in Tissue

  48-72 hours

• Tedizolid AUC in Plasma

  48-72 hours

Study Arms (2)

Diabetic Wound Infection

EXPERIMENTAL

Participants with a documented medical history of Type 1 or Type 2 diabetes and a mild to moderate (Grade 2 or 3) wound infection of the lower limb will receive 3 to 6 doses of oral tedizolid 200mg once daily, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 24 hours following the last dose (e.g., 48-72 hours).

Drug: Tedizolid; Procedure: Microdialysis Catheter Insertion

Healthy Volunteers

ACTIVE COMPARATOR

Participants will be male or female healthy adult volunteers with no significant medical or medication history. Participants will receive 3 to 6 doses of oral tedizolid 200mg once daily, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 24 hours following the last dose (e.g., 48-72 hours).

Drug: Tedizolid; Procedure: Microdialysis Catheter Insertion

Interventions

Tedizolid DRUG

Also known as: Sivextro

Diabetic Wound Infection; Healthy Volunteers

Microdialysis Catheter Insertion PROCEDURE

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.

Diabetic Wound Infection; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experimental: Type 1 or Type 2 diabetes and a mild to moderate (Grade 2 or 3) wound infection of the lower limb
• Active Comparator: Healthy Adult Volunteer

You may not qualify if:

• All Participants:
• Less than 18 years of age
• History of hypersensitivity to tedizolid or linezolid
• History of hypersensitivity to lidocaine or lidocaine derivatives
• Pregnant or breastfeeding
• Presence of anemia, thrombocytopenia, or leukopenia as defined by hematocrit, platelet, or white blood cell count \< 75% of the lower limit of normal
• Concomitant receipt of linezolid
• Any other reason felt by the investigator to potentially affect the outcomes of the study
• Experimental Group Only:
• No palpable pedal pulses present
• Participants likely to require multiple surgical interventions during the study period, which therefore could affect placement of the microdialysis catheter
• Active Comparator Group Only:
• Positive urine drug screen (cocaine, tetrahydrocannabinol, opiates, benzodiazepines, and amphetamines).
• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
• Use of tobacco- or nicotine-containing products in excess of the equivalence of 5 cigarettes per day.

Sponsors & Collaborators

• Hartford Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Wound Infection

Interventions

tedizolid; tedizolid phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Infections

Results Point of Contact

• Title: Dr. David P. Nicolau
• Organization: Center for Anti Infective Research and Development

david.nicolau@hhchealth.org

(860) 972-3941

Study Officials

• David P Nicolau, PharmD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: February 23, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: January 15, 2019
• Results First Posted: January 15, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)