- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04144374
Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis
August 23, 2021 updated by: Hartford Hospital
Comparison of Omadacycline Pharmacokinetics and Soft-Tissue Penetration in Diabetic Patients With Wound Infections Versus Healthy Volunteers Via In Vivo Microdialysis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 5 doses of omadacycline (200mg IV once daily on day 1, transitioned to 300 mg by mouth thereafter).
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 normal saline 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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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Hartford, Connecticut, United States, 06102
- Hartford Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
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
Additional Exclusion Criteria for Diabetic Patient Study Group:
- 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
- Positive urine drug screen (cocaine, THC, 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.
- Consumption of caffeine between Study Days 1 and 4
- 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. The use of hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) are permitted.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Diabetic Wound Infection
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).
|
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.
Other Names:
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.
|
ACTIVE_COMPARATOR: Healthy Volunteers
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).
|
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.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Omadacycline Tissue Penetration.
Time Frame: 48-72 hours
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The ratio of omadacycline tissue concentrations to blood concentrations following the final omadacycline dose.
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48-72 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Omadacycline Area Under the Curve (AUC) in Tissue
Time Frame: 48-72 hours
|
he area under the drug concentration-time curve (AUC) in tissue reflects the actual tissue exposure to drug after administration of a dose of the drug and is expressed in mg*h/L.
Venous blood was obtained via peripheral intravenous catheter at 48 hours from the start of the first dose (i.e., immediately before administration of the 3rd dose), and at 49, 50, 50.5, 51, 51.5, 52, 54, 56, 60, 64 and 72 hours.
Dialysate samples of 120μL were collected in 200µL microvials simultaneously with plasma at 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 64, 68 and 72 hours following administration of the first dose.
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48-72 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David P Nicolau, PharmD, Center for Anti-Infective Research and Development, Hartford Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 10, 2020
Primary Completion (ACTUAL)
July 12, 2021
Study Completion (ACTUAL)
July 29, 2021
Study Registration Dates
First Submitted
October 28, 2019
First Submitted That Met QC Criteria
October 28, 2019
First Posted (ACTUAL)
October 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 25, 2021
Last Update Submitted That Met QC Criteria
August 23, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHC-2019-0220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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