Condition or disease | Intervention/treatment | Phase |
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Diabetes Wound Infection ABSSSI Healthy Volunteers | Drug: Tebipenem Pivoxil Hydrobromide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Pharmacokinetics and Soft-Tissue Penetration of Tebipenem (SPR994) in Healthy Volunteer Subjects and Diabetic Patients With Lower Limb Infections |
Estimated Study Start Date : | August 2021 |
Estimated Primary Completion Date : | August 2022 |
Estimated Study Completion Date : | August 2022 |
Arm | Intervention/treatment |
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Experimental: Diabetic Wound Infection
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.
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Drug: Tebipenem Pivoxil Hydrobromide
Tebipenem 300 mg or 600 mg will be administered orally every 8 hours for total of 3 to 7 doses
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Active Comparator: Healthy Volunteers
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.
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Drug: Tebipenem Pivoxil Hydrobromide
Tebipenem 300 mg or 600 mg will be administered orally every 8 hours for total of 3 to 7 doses
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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:
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:
Additional Exclusion Criteria for Diabetic Patient Study Group
Additional Exclusion Criteria for Healthy Volunteer Control Group
Contact: Tomefa E Asempa, PharmD | 8609721109 | tomefa.asempa@hhchealth.org | |
Contact: David P Nicolau, PharmD | 860-972-3941 | david.nicolau@hhchealth.org |
United States, Connecticut | |
Hartford Hospital | |
Hartford, Connecticut, United States, 06102 | |
Contact: Tomefa E Asempa, PharmD 860-972-1109 tomefa.asempa@hhchealth.org | |
Contact: David P Nicolau, PharmD 860-972-3941 david.nicolau@hhchealth.org |
Principal Investigator: | Tomefa E Asempa, PharmD | Hartford Hospital |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 3, 2021 | ||||||||
First Posted Date ICMJE | June 9, 2021 | ||||||||
Last Update Posted Date | June 9, 2021 | ||||||||
Estimated Study Start Date ICMJE | August 2021 | ||||||||
Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Tebipenem Pivoxil Hydrobromide Tissue Penetration [ Time Frame: 8 hours ] The ratio of tebipenem tissue concentrations to blood concentrations following the final tebipenem dose
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
Tebipenem Pivoxil Hydrobromide Area Under the Curve (AUC) in Tissue [ Time Frame: 8 hours ] The area under the drug concentration-time curve (AUC) in tissue reflects the actual tissue exposure to drug after administration of a dose of the drug and is expressed in mg*h/L. Venous blood will be obtained via peripheral intravenous catheter immediately before administration of the last dose (pre-dose timepoint), and at 9 time-points post-dose. Dialysate samples of 120μL will be collected in 200µL microvials simultaneously with plasma samples.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis | ||||||||
Official Title ICMJE | Pharmacokinetics and Soft-Tissue Penetration of Tebipenem (SPR994) in Healthy Volunteer Subjects and Diabetic Patients With Lower Limb Infections | ||||||||
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. | ||||||||
Detailed Description | This study will enroll 10 patients with diabetes who are admitted with a lower limb wound infection and 6 healthy volunteer control participants. The study will take place in an inpatient unit at Hartford Hospital for all patients and in the Clinical Research Center at Hartford Hospital for all healthy volunteers. All participants will receive 3 to 7 doses of tebipenem pivoxil hydrobromide (300 mg or 600 mg orally every 8 hours depending on renal function). A microdialysis probe (Mdialysis Inc., N. Chelmsford, MA) will be inserted into the subcutaneous soft tissue near the margin of the wound (patients) or in the thigh (healthy volunteers). The microdialysis probe is perfused with normal saline solution and samples are collected for the 8 hours following the final dose. A peripheral intravenous catheter will be inserted into an arm vein to collect blood samples simultaneously with microdialysis samples. Concentrations in tissue are compared with blood to determine percent penetration. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE | Drug: Tebipenem Pivoxil Hydrobromide
Tebipenem 300 mg or 600 mg will be administered orally every 8 hours for total of 3 to 7 doses
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
16 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | August 2022 | ||||||||
Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
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:
Additional Exclusion Criteria for Diabetic Patient Study Group
Additional Exclusion Criteria for Healthy Volunteer Control Group
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04919954 | ||||||||
Other Study ID Numbers ICMJE | HHC-2021-0109 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Hartford Hospital | ||||||||
Study Sponsor ICMJE | Hartford Hospital | ||||||||
Collaborators ICMJE | Spero Therapeutics Inc | ||||||||
Investigators ICMJE |
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PRS Account | Hartford Hospital | ||||||||
Verification Date | June 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |