A Phase 1 interventional study of Tedizolid and Microdialysis Catheter Insertion in Diabetes, Wound Infection and Healthy Volunteers, sponsored by Hartford Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by Hartford Hospital · Phase 1, Interventional, and Other
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 18 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Hartford Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All Participants:
Experimental Group Only:
Active Comparator Group Only:
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
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
Also known as: Sivextro
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.
Tedizolid Tissue Penetration
The ratio of tedizolid tissue concentrations to blood concentrations following the final tedizolid dose
Time frame: 48-72 hours
Tedizolid Area Under the Curve (AUC) in Tissue
The 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.
Time frame: 48-72 hours
Tedizolid AUC in Plasma
The area under the plasma drug concentration-time curve (AUC) reflects the actual plasma exposure to drug after administration of a dose of the drug and is expressed in mg\*h/L
Time frame: 48-72 hours
| Milestone | Diabetic Wound Infection | Healthy Volunteers |
|---|---|---|
| Started | 12 | 6 |
| Completed | 10 | 6 |
| Not completed | 2 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Eligibility criteria not met | 1 | 0 |
The ratio of tedizolid tissue concentrations to blood concentrations following the final tedizolid dose
| ratio | Diabetic Wound Infection | Healthy Volunteers |
|---|---|---|
| Tedizolid Tissue Penetration | 0.98 ± 0.43 | 0.82 ± 0.08 |
The 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.
| mg*h/L | Diabetic Wound Infection | Healthy Volunteers |
|---|---|---|
| Tedizolid Area Under the Curve (AUC) in Tissue | 3.44 ± 1.50 | 5.20 ± 1.61 |
The area under the plasma drug concentration-time curve (AUC) reflects the actual plasma exposure to drug after administration of a dose of the drug and is expressed in mg\*h/L
| mg*h/L | Diabetic Wound Infection | Healthy Volunteers |
|---|---|---|
| Tedizolid AUC in Plasma | 18.47 ± 9.70 | 28.71 ± 9.58 |
Collected over Adverse events were collected over a 76 hour window, from the start of first tedizolid dose (0 hour) to the end of blood/dialysate sampling (72 hours), plus a 4 hour observation window after the last sample was collected for subjects who received at least one dose of tedizolid. Note. In the diabetic wound infection group, 12 subjects were enrolled, but 11 received at least one dose. Therefore, the denominator is different from what is listed in the participant flow.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diabetic Wound Infection | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) |
| Healthy Volunteers | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Event | Diabetic Wound Infection | Healthy Volunteers |
|---|---|---|
| HeadacheNervous system disorders | 0/11 | 3/6 |
| HypothermiaGeneral disorders | 1/11 | 0/6 |
| NauseaGastrointestinal disorders | 1/11 | 0/6 |
| Age, Continuous(years) | Diabetic Wound Infection | Healthy Volunteers | Total |
|---|---|---|---|
| Mean | 51 ± 17 | 33 ± 9 | 44 ± 17 |
| Sex: Female, Male(Participants) | Diabetic Wound Infection | Healthy Volunteers | Total |
|---|---|---|---|
| Female | 5 | 3 | 8 |
| Male | 5 | 3 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Diabetic Wound Infection | Healthy Volunteers | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 0 | 8 |
| Not Hispanic or Latino | 2 | 6 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Diabetic Wound Infection | Healthy Volunteers | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 10 | 5 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Diabetic Wound Infection | Healthy Volunteers | Total |
|---|---|---|---|
| United States | 10 | 6 | 16 |
| Body Mass Index(kg/m^2) | Diabetic Wound Infection | Healthy Volunteers | Total |
|---|---|---|---|
| Mean | 31.5 ± 6.3 | 28.5 ± 5.4 | 30.4 ± 6.0 |
| Weight(kg) | Diabetic Wound Infection | Healthy Volunteers | Total |
|---|---|---|---|
| Mean | 89.4 ± 21 | 79.5 ± 17.9 | 85.7 ± 19.9 |
| Height(inches) | Diabetic Wound Infection | Healthy Volunteers | Total |
|---|---|---|---|
| Mean | 66.6 ± 5.0 | 65.7 ± 4.5 | 66.3 ± 4.7 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hartford Hospital