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NCT02620774 · ClinicalTrials.gov registry record · Phase 1
Tissue Penetration of Ceftolozane/Tazobactam in Diabetic Patients With Lower Limb Infections
A Phase 1 study of Diabetes and Healthy Volunteers, sponsored by Hartford Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02620774: Completed Phase 1 study of Diabetes and Healthy Volunteers, sponsored by Hartford Hospital.
NCT02620774 is a Phase 1 study of Diabetes and Healthy Volunteers that has completed, run by Hartford Hospital. The registered enrollment target is 16 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02620774, a Phase 1 study of Diabetes and Healthy Volunteers, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine the tissue penetration of ceftolozane/tazobactam (Zerbaxa, Merck \& Co.), a novel β-lactam/β-lactamase combination antibiotic, 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 ceftolozane tissue concentration area under the curve (AUC) to plasma concentrations AUC following the final (i.e., 3rd) ceftolozane/tazobactam dose. Note. Ceftolozane/tazobactam doses were administered at 0, 8, and 16 hours. Plasma and dialysate concentrations were determined at hours 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours after the first dose for determination of ceftolozane AUC in blood and tissue.
Conditions Studied
Interventions
- DRUG Ceftolozane/tazobactam
- PROCEDURE Microdialysis Catheter Insertion
Study Locations (1)
Connecticut
- Hartford Hospital - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2016-02-19 |
| Est. Completion | 2017-04 |
| Phase | Phase 1 |
What the finished NCT02620774 record still lists
NCT02620774 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Ceftolozane/tazobactam is the first listed.
NCT02620774 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT02620774 about?
NCT02620774 is a clinical study titled "Tissue Penetration of Ceftolozane/Tazobactam in Diabetic Patients With Lower Limb Infections". This study will determine the tissue penetration of ceftolozane/tazobactam (Zerbaxa, Merck \& Co.), a novel β-lactam/β-lactamase combination antibiotic, into the extracellular, interstitial fluid of soft tissue in diabetic patients with lower limb wound infections. Penetration will be compared with ...
What is the current status of trial NCT02620774?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2016-02-19. Estimated completion is 2017-04.
What conditions does trial NCT02620774 study?
This clinical trial studies the following conditions: Diabetes, Healthy Volunteers, Wound Infection.
What interventions are being tested in trial NCT02620774?
The interventions under investigation include: Ceftolozane/tazobactam (DRUG), Microdialysis Catheter Insertion (PROCEDURE).
Who is sponsoring clinical trial NCT02620774?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02620774 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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16 319th of 338 higher than 17 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
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