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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02620787
• Date of registration: 01/12/2015
• Prospective Registration: Yes
• Primary sponsor: Hartford Hospital
• Public title: Tedizolid Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis
• Scientific title: Comparative Assessment of Tedizolid Tissue Penetration and Pharmacokinetic Profile Between Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis
• Date of first enrolment: February 23, 2016
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02620787
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: David P Nicolau, PharmD
• Affiliation: Hartford Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Wound Infection

Diabetes

Healthy Volunteers

Intervention(s)

Drug: Tedizolid

Procedure: Microdialysis Catheter Insertion

Primary Outcome(s)

Tedizolid Tissue Penetration [Time Frame: 48-72 hours]

Secondary Outcome(s)

Tedizolid Area Under the Curve (AUC) in Tissue [Time Frame: 48-72 hours]

Tedizolid AUC in Plasma [Time Frame: 48-72 hours]

Secondary ID(s)

Nicolau-53466

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme Corp.

Results

• Results available: Yes
• Date Posted: 15/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02620787