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Carbapenem
Tebipenem Pivoxil Hydrobromide for Healthy Subjects
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
Study Summary
This study is evaluating whether a carbapenem can penetrate the skin and reach the bloodstream in people with diabetes.
Eligible Conditions
- Diabetes
- Healthy Subjects
- Bacterial Skin and Skin Structure Infection
- Wound Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tebipenem Pivoxil Hydrobromide Tissue Penetration
Secondary outcome measures
Tebipenem Pivoxil Hydrobromide Area Under the Curve (AUC) in Tissue
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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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Hartford HospitalLead Sponsor
132 Previous Clinical Trials
18,910 Total Patients Enrolled
Spero TherapeuticsIndustry Sponsor
22 Previous Clinical Trials
4,824 Total Patients Enrolled
Spero Therapeutics IncUNKNOWN
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