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

NCT04144374 | Completed Phase 1 FDA Drug

• 1 other identifier: HHC-2019-0220
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the tissue penetration of the novel tetracycline antibiotic, omadacycline (Nuzyra, Paratek Pharmaceuticals, Inc.), 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)

• Omadacycline Tissue Penetration.

  The ratio of omadacycline tissue concentrations to blood concentrations following the final omadacycline dose.

  48-72 hours

Secondary Outcomes (1)

• Omadacycline Area Under the Curve (AUC) in Tissue

  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 5 doses of omadacycline 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: Omadacycline; 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 doses of omadacycline 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: Omadacycline; Procedure: Microdialysis Catheter Insertion

Interventions

Omadacycline DRUG

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.

Also known as: Nuzyra

Diabetic Wound Infection; Healthy Volunteers

Microdialysis Catheter Insertion PROCEDURE

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.

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:

• Participants in the study or control group will be excluded if any of the following criteria are met:
• Less than 18 years of age
• History of hypersensitivity to omadacycline or any tetracycline based molecule
• History of hypersensitivity to lidocaine or lidocaine derivatives
• Pregnant or breastfeeding
• Concomitant receipt of any tetracycline based antibiotic therapy
• Any other documented reason felt by the investigator to potentially affect the outcomes of the study
• Participants likely to require multiple surgical interventions during the study period, which therefore could affect placement of the microdialysis catheter
• Additional Criteria for Healthy Volunteer Control Group:
• Body Mass Index (BMI) ≥ 35 kg/m2
• Serum creatinine greater than 1.5 mg/dl or creatinine clearance (CrCl) \< 50ml/min, as calculated by Cockroft-Gault using ideal body weight for all participants
• Presence of anemia, thrombocytopenia, or leukopenia as defined by hematocrit, platelet, or white blood cell count \< 75% of the lower limit of normal
• Aspartate transaminase, alanine aminotransferase, or alkaline phosphatase greater than five times upper limit of normal
• Total bilirubin greater than three times the upper limit of normal
• Any known active co-morbidity listed on medical history or that becomes apparent during physical examination

Sponsors & Collaborators

• Hartford Hospital: lead
• Paratek Pharmaceuticals Inc: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Wound Infection

Interventions

omadacycline

Condition Hierarchy (Ancestors)

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

Study Officials

• David P Nicolau, PharmD

  Center for Anti-Infective Research and Development, Hartford Hospital

  PRINCIPAL INVESTIGATOR

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: October 28, 2019
• First Posted: October 30, 2019
• Study Start: February 10, 2020
• Primary Completion: July 12, 2021
• Study Completion: July 29, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)