Tebipenem Pivoxil Hydrobromide for Wound Infection

Phase 1

Waitlist Available

Led By Tomefa E Asempa, PharmD

Research Sponsored by Hartford Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 hours

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Wound Infection
Healthy Subjects
Diabetes
Bacterial Skin and Skin Structure Infection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tebipenem Pivoxil Hydrobromide Tissue Penetration

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Diabetic Wound InfectionExperimental Treatment1 Intervention

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.

Group II: Healthy VolunteersActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tebipenem Pivoxil Hydrobromide

2021

Completed Phase 1

~20

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