Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

NCT04919954 ↗

Phase 1 Completed 12 enrolled Hartford Hospital Spero Therapeutics · collab

Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

Start: 2021-07-01
Primary completion: 2022-08-30
Completion: 2022-12-23

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tebipenem	Small molecule	300 mg	Oral
Subject	Tebipenem	Small molecule	600 mg	Oral

Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

Summary

Timeline

Drugs

Indications