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

NCT04919954 | Completed Phase 1 FDA Drug

• 1 other identifier: HHC-2021-0109
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Wound Infection; ABSSSI; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Tebipenem Pivoxil Hydrobromide Tissue Penetration

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

  8 hours

Secondary Outcomes (1)

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

  8 hours

Study Arms (2)

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.

Drug: Tebipenem Pivoxil Hydrobromide

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.

Drug: Tebipenem Pivoxil Hydrobromide

Interventions

Tebipenem Pivoxil Hydrobromide DRUG

Tebipenem 300 mg or 600 mg will be administered orally every 8 hours for total of 3 to 7 doses

Diabetic Wound Infection; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Participants in the diabetic wound group or healthy volunteer group will be excluded if any of the following criteria are met:
• Less than 18 years of age
• History of hypersensitivity or allergy to tebipenem or its derivatives and any β-lactam antibiotic
• History of hypersensitivity to lidocaine or lidocaine derivatives
• Concurrently receiving probenecid.
• Males who are not surgically sterilized (with female partners of childbearing potential) and females of childbearing potential must agree to use two highly effective methods of contraception from screening, during this trial, and for 90 days after the last dose of study drug. A woman is considered of childbearing potential unless postmenopausal (≥1 year without menses) or surgically sterilized via bilateral oophorectomy, hysterectomy, bilateral tubal ligation, or successful Essure® placement with a documented confirmation test at least 90 days after the procedure. Highly effective contraception is defined as a method of contraception that has a less than 1% failure rate when used consistently and correctly. These methods are as follows:
• Hormonal contraceptives (eg, combined oral contraceptives, patch, vaginal ring, injectables, and implants).
• Intrauterine device or intrauterine system.
• Double-barrier methods of contraception (eg, male condom with diaphragm or male condom with cervical cap).
• Monogamous relationship with a vasectomized partner.
• Total abstinence, in accordance with the lifestyle of the subject.
• Any other documented reason felt by the investigator to potentially affect the outcomes of the study
• Participants likely to require multiple surgical interventions during the study period, which could affect placement of the microdialysis catheter
• Creatinine clearance (CrCl) \< 30ml/min, as calculated by Cockroft-Gault using ideal body weight
• Body Mass Index (BMI) ≥ 35 kg/m2

Sponsors & Collaborators

• Hartford Hospital: lead
• Spero Therapeutics: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Wound Infection

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Infections

Study Officials

• Tomefa E Asempa, PharmD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 9, 2021
• Study Start: July 1, 2021
• Primary Completion: August 30, 2022
• Study Completion: December 23, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)