Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04919954 | Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis | PHASE1 | COMPLETED | 12 | — | — | Jul 1, 2021 | Dec 23, 2022 | Oct 23, 2023 | 1 | United States |
The ratio of tebipenem tissue concentrations to blood concentrations following the final tebipenem dose
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Tebipenem Pivoxil Hydrobromide | DRUG | Tebipenem 300 mg or 600 mg will be administered orally every 8 hours for total of 3 to 7 doses |
Exclusion Criteria - All patients/participants Participants in the diabetic wound group or healthy volunteer group will be excluded if any of the following criteria are met: 1. Less than 18 years of age 2. History of hypersensitivity or allergy to tebipenem or its derivatives and any β-lactam anti...