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

NCT04919954 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-10-23

No results posted yet for this study

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

Interventions

DRUG

Tebipenem Pivoxil Hydrobromide

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

Sponsors & Collaborators

  • Spero Therapeutics

    collaborator INDUSTRY

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Tomefa E Asempa, PharmD · Hartford Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-08-30
Completion
2022-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04919954 on ClinicalTrials.gov