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临床试验/NCT04919954
NCT04919954已完成1 期

Pharmacokinetics and Soft-Tissue Penetration of Tebipenem (SPR994) in Healthy Volunteer Subjects and Diabetic Patients With Lower Limb Infections

Hartford Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Tebipenem Pivoxil Hydrobromide Tissue Penetration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

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 tebipenem, followed by sampling of interstitial tissue fluid by a microdialysis probe inserted in a thigh over 8 hours following the last dose.

干预措施: Tebipenem Pivoxil Hydrobromide (Drug)

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 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.

干预措施: Tebipenem Pivoxil Hydrobromide (Drug)

结局指标

主要结局

Tebipenem Pivoxil Hydrobromide Tissue Penetration

时间窗: 8 hours

The ratio of tebipenem tissue concentrations to blood concentrations following the final tebipenem dose

次要结局

  • Tebipenem Pivoxil Hydrobromide Area Under the Curve (AUC) in Tissue(8 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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