Pharmacokinetics and Soft-Tissue Penetration of Tebipenem (SPR994) in Healthy Volunteer Subjects and Diabetic Patients With Lower Limb Infections
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Hartford Hospital
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Tebipenem Pivoxil Hydrobromide Tissue Penetration
Study Overview
Brief Summary
This study will determine the tissue penetration of a broad-spectrum orally bioavailable carbapenem, tebipenem pivoxil hydrobromide (SPR994) (Spero Therapeutics, 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.
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 7 doses of tebipenem pivoxil hydrobromide (300 mg or 600 mg orally every 8 hours depending on renal function). 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 8 hours following the final dose. 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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Healthy Volunteers
Participants will be male or female healthy adult volunteers with no significant medical or medication history. Participants will receive 3 doses of tebipenem, followed by sampling of interstitial tissue fluid by a microdialysis probe inserted in a thigh over 8 hours following the last dose.
Intervention: Tebipenem Pivoxil Hydrobromide (Drug)
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 7 doses of tebipenem, followed by sampling of interstitial tissue fluid at the margin of the wound by a microdialysis probe over 8 hours following the last dose.
Intervention: Tebipenem Pivoxil Hydrobromide (Drug)
Outcomes
Primary Outcomes
Tebipenem Pivoxil Hydrobromide Tissue Penetration
Time Frame: 8 hours
The ratio of tebipenem tissue concentrations to blood concentrations following the final tebipenem dose
Secondary Outcomes
- Tebipenem Pivoxil Hydrobromide Area Under the Curve (AUC) in Tissue(8 hours)