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

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 3 to 6 doses of
oral tedizolid 200mg once daily. 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 for the 24 hours following the final dose (i.e., 48-72
hours). 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.

Inclusion Criteria:

- 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

Exclusion Criteria:

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.

- Use of prescription or nonprescription drugs, vitamins, or dietary supplements within
7 days or 5 half-lives (whichever is longer) prior to the first dose of study
medication, with the exception of acetaminophen at doses of ≤ 1 g/day. Herbal
supplements, hormonal methods of contraception (including oral and transdermal
contraceptives, injectable progesterone, progestin subdermal implants,
progesterone-releasing intrauterine devices (IUDs), postcoital contraceptive methods),
and hormone replacement therapy must be discontinued at least 14 days prior to the
first dose of study medication. Depo-Provera® must be discontinued at least 6 months
prior to the first dose of study medication.