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NCT03426761 · ClinicalTrials.gov registry record · Phase 4
Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections
A Phase 4 study of Prosthetic-joint Infection and Joint Infection, sponsored by Infectious Diseases Physicians.
- Completed
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT03426761: Completed Phase 4 study of Prosthetic-joint Infection and Joint Infection, sponsored by Infectious Diseases Physicians.
NCT03426761 is a Phase 4 study of Prosthetic-joint Infection and Joint Infection that has completed, run by Infectious Diseases Physicians. The registered enrollment target is 41 participants, below the 94-participant average among 9 other Prosthetic-joint Infection trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03426761, a Phase 4 study of Prosthetic-joint Infection and Joint Infection, has completed, sponsored by Infectious Diseases Physicians.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
Because of its prolonged terminal half-life, dalbavancin is an extremely attractive option in treating Gram-positive infections caused by S. aureus including MRSA, and streptococcal species. Systemic bacterial infections due to Staphylococci such as osteomyelitis and septic arthritis, are conditions which require prolonged IV therapy, typically for at least 3-6 weeks, though sometimes more. Due to dalbavancin's prolonged terminal half-life, it may offer the opportunity to substantially reduce costs and morbidity in native joint and prosthetic joint infections with one infusion every fourteen days until completion of therapy.
Primary Outcome
This is defined as the absence of wound drainage, sinus tract formation, fever or joint instability at study day 42, without having switched or extended treatment for any reason. This will be reported as the % of participants from each treatment arm, who are determined to be a treatment responder.
Conditions Studied
Interventions
- DRUG Vancomycin
- DRUG Dalbavancin
Study Locations (1)
Virginia
- Infectious Diseases Physicians, Inc. - Annandale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-01-25 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 4 |
What the finished NCT03426761 record still lists
NCT03426761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 94-participant average among 9 other Prosthetic-joint Infection trials with a reported enrollment target (56% lower).
The record links to 5 conditions, with Prosthetic-joint Infection appearing as the primary indexed condition, and to 2 interventions - of which Vancomycin is the first listed.
NCT03426761 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03426761 about?
NCT03426761 is a clinical study titled "Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections". Because of its prolonged terminal half-life, dalbavancin is an extremely attractive option in treating Gram-positive infections caused by S. aureus including MRSA, and streptococcal species. Systemic bacterial infections due to Staphylococci such as osteomyelitis and septic arthritis, are conditions...
What is the current status of trial NCT03426761?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2018-01-25. Estimated completion is 2022-12-31.
What conditions does trial NCT03426761 study?
This clinical trial studies the following conditions: Prosthetic-joint Infection, Joint Infection, Septic Arthritis, Osteomyelitis, Bone Infection.
What interventions are being tested in trial NCT03426761?
The interventions under investigation include: Vancomycin (DRUG), Dalbavancin (DRUG).
Who is sponsoring clinical trial NCT03426761?
This trial is sponsored by Infectious Diseases Physicians, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03426761 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03426761's enrollment target sits among peer trials
41 8th of 9 higher than 2 of 9 other Prosthetic-joint Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prosthetic-joint Infection 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.
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