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NCT04144374 · ClinicalTrials.gov registry record · Phase 1

Omadacycline 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
14
Enrollment target

NCT04144374 is a Phase 1 study that has completed, run by Hartford Hospital. The registered enrollment target is 14 participants.

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The verdict

NCT04144374, a Phase 1 study, has completed, sponsored by Hartford Hospital.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

This study will determine the tissue penetration of the novel tetracycline antibiotic, omadacycline (Nuzyra, Paratek Pharmaceuticals, 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.

Interventions

  • DRUG Omadacycline
  • PROCEDURE Microdialysis Catheter Insertion

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2020-02-10
Est. Completion 2021-07-29
Phase Phase 1

Sponsor

Hartford Hospital

75 total trials

What the Registry Record Tells You About NCT04144374

The ClinicalTrials.gov registry entry for NCT04144374 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Omadacycline is the first listed.

NCT04144374 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04144374 about?

NCT04144374 is a clinical study titled "Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis". This study will determine the tissue penetration of the novel tetracycline antibiotic, omadacycline (Nuzyra, Paratek Pharmaceuticals, 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 h...

What is the current status of trial NCT04144374?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2020-02-10. Estimated completion is 2021-07-29.

What interventions are being tested in trial NCT04144374?

The interventions under investigation include: Omadacycline (DRUG), Microdialysis Catheter Insertion (PROCEDURE).

Who is sponsoring clinical trial NCT04144374?

This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.