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NCT05369052 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)
A Phase 3 study of Diabetic Foot Infection, sponsored by MicuRx.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 865
- Enrollment target
- 14
- Study locations
NCT05369052: Recruiting Phase 3 study of Diabetic Foot Infection, sponsored by MicuRx.
NCT05369052 is a Phase 3 study of Diabetic Foot Infection that is actively recruiting participants, run by MicuRx. The registered enrollment target is 865 participants, above the 455-participant average among 5 other Diabetic Foot Infection trials with a reported enrollment target (90% higher). The trial reports 14 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05369052, a Phase 3 study of Diabetic Foot Infection, is actively recruiting participants, sponsored by MicuRx.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 865 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.
Primary Outcome
The primary objective is to evaluate the Investigator's assessment of clinical response at the D35 visit in subjects receiving contezolid acefosamil/contezolid compared to subjects receiving linezolid in the MITT analysis
Conditions Studied
Interventions
- DRUG contezolid acefosamil (IV)/contezolid (PO)
- DRUG Linezolid (IV and PO)
Study Locations (14)
Other
- MHAT Sveti Nikolay Chudotvorets EOOD - Lom
- Multiprofile Hospital for Active Treatment - KANEV - Rousse
- Medical Institute Ministry of Interior Central Clinical Base - Sofia
- University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´ - Sofia
- South-Estonian Hospital Ltd. - Võru
- LTD High Technology Hospital Med Center - Batumi
- JSC Vian - West Georgia Medical Center - Kutaisi
- GMV Care& Research - Maria Cecilia Hospital - Cotignola
- Daugavpils Regional Hospital - Daugavpils
- Instytut Medycyny Wsi im. W. Chodzki - Lublin
- PODEMA Sp. z o.o. - Warsaw
- University Clinical Center Kragujevac - Kragujevac
California
- New Hope Research Development - Corona
- ILD Research Center - Vista
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 865 participants |
| Start Date | 2022-05-03 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What NCT05369052 shows while recruiting
NCT05369052 is an interventional study that assigns participants to a tested intervention. The registered 865 participants enrollment target is mid-sized for trials with a published cap, above the 455-participant average among 5 other Diabetic Foot Infection trials with a reported enrollment target (90% higher).
The record links to 1 condition, with Diabetic Foot Infection appearing as the primary indexed condition, and to 2 interventions - of which contezolid acefosamil (IV)/contezolid (PO) is the first listed.
NCT05369052 lists 14 locations in 2 states (Other, California).
Frequently Asked Questions
What is clinical trial NCT05369052 about?
NCT05369052 is a clinical study titled "Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)". This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.
What is the current status of trial NCT05369052?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 865 participants. The study started on 2022-05-03. Estimated completion is 2026-06-30.
What conditions does trial NCT05369052 study?
This clinical trial studies the following conditions: Diabetic Foot Infection.
What interventions are being tested in trial NCT05369052?
The interventions under investigation include: contezolid acefosamil (IV)/contezolid (PO) (DRUG), Linezolid (IV and PO) (DRUG).
Who is sponsoring clinical trial NCT05369052?
This trial is sponsored by MicuRx, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05369052 being conducted?
This trial has 14 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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