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NCT04919954 · ClinicalTrials.gov registry record · Phase 1
Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis
A Phase 1 study, sponsored by Hartford Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04919954: Completed Phase 1 study, sponsored by Hartford Hospital.
NCT04919954 is a Phase 1 study that has completed, run by Hartford Hospital. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04919954, a Phase 1 study, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
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.
Primary Outcome
The ratio of tebipenem tissue concentrations to blood concentrations following the final tebipenem dose
Interventions
- DRUG Tebipenem Pivoxil Hydrobromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2022-12-23 |
| Phase | Phase 1 |
What the finished NCT04919954 record still lists
NCT04919954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Tebipenem Pivoxil Hydrobromide is the first listed.
NCT04919954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04919954 about?
NCT04919954 is a clinical study titled "Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis". 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 b...
What is the current status of trial NCT04919954?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-07-01. Estimated completion is 2022-12-23.
What interventions are being tested in trial NCT04919954?
The interventions under investigation include: Tebipenem Pivoxil Hydrobromide (DRUG).
Who is sponsoring clinical trial NCT04919954?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04919954's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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