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NCT04714411 · ClinicalTrials.gov registry record
Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis
A clinical trial of Diabetic Foot Infection, sponsored by Methodist Health System.
- Recruiting
- Registry status
- 600
- Enrollment target
- 2
- Study locations
NCT04714411: Recruiting study of Diabetic Foot Infection, sponsored by Methodist Health System.
NCT04714411 is a study of Diabetic Foot Infection that is actively recruiting participants, run by Methodist Health System. The registered enrollment target is 600 participants, above the 508-participant average among 5 other Diabetic Foot Infection trials with a reported enrollment target (18% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04714411, a study of Diabetic Foot Infection, is actively recruiting participants, sponsored by Methodist Health System.
- RECRUITING
- Registry status
- 600 participants
- Enrollment target
- 2
- Study locations
Study Summary
This will be a prospective, open-label, two-center study to assess the safety of omadacycline use in the treatment of hospitalized subjects with moderate to severe DFI with or without Acute osteomyelitis (AOM) who are at a high risk for development of CDI, AKI, and/or resistant pathogens compared to retrospective controls. Prospective enrollment will be continued until the sample size is achieved up to one year from start date (October 2020). Secondary to slower than anticipated enrollment due to the COVID-19 pandemic and initial exclusion of AOM, following protocol amendment, patient enrollment will be continued until the sample size is achieved up to 18 months from amendment approval (anticipate April 2022 - October 2023). A historical matched case cohort (standard of care) at the two hospitals based on ICD10 codes associated with DFI \[E11.(621, 622), E10.(621, 622); L97.(509, 521, 522, 523, 524, 529)\], including subjects with AOM \[M86.(08-09, 10, 16-19, 8X0, 8X7-8X9, 9) will be utilized for comparison.
Primary Outcome
Risk, injury, failure, loss and ESRD
Conditions Studied
Interventions
- DRUG Omadacycline
Study Locations (2)
Texas
- Methodist Dallas Medical Center - Dallas
- Methodist Charlton Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2020-11-05 |
| Est. Completion | 2025-08-18 |
What NCT04714411 shows while recruiting
NCT04714411 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 508-participant average among 5 other Diabetic Foot Infection trials with a reported enrollment target (18% higher).
The record links to 1 condition, with Diabetic Foot Infection appearing as the primary indexed condition, and to 1 intervention - of which Omadacycline is the first listed.
NCT04714411 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04714411 about?
NCT04714411 is a clinical study titled "Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis". This will be a prospective, open-label, two-center study to assess the safety of omadacycline use in the treatment of hospitalized subjects with moderate to severe DFI with or without Acute osteomyelitis (AOM) who are at a high risk for development of CDI, AKI, and/or resistant pathogens compared to...
What is the current status of trial NCT04714411?
This trial is currently recruiting. The enrollment target is 600 participants. The study started on 2020-11-05. Estimated completion is 2025-08-18.
What conditions does trial NCT04714411 study?
This clinical trial studies the following conditions: Diabetic Foot Infection.
What interventions are being tested in trial NCT04714411?
The interventions under investigation include: Omadacycline (DRUG).
Who is sponsoring clinical trial NCT04714411?
This trial is sponsored by Methodist Health System, which has 125 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04714411 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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