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NCT03721328 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
A Phase 2 study of Prosthetic-joint Infection, sponsored by Osteal Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 4
- Study locations
NCT03721328 is a Phase 2 study of Prosthetic-joint Infection that has completed, run by Osteal Therapeutics. The registered enrollment target is 15 participants, below the 97-participant average among 9 other Prosthetic-joint Infection trials with a reported enrollment target (85% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT03721328, a Phase 2 study of Prosthetic-joint Infection, has completed, sponsored by Osteal Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 4
- Study locations
Study Summary
Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI. Primary Outcome Measure The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions. Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.
Conditions Studied
Interventions
- COMBINATION_PRODUCT vancomycin hydrochloride and tobramycin sulfate
Study Locations (4)
Michigan
- Covenant Hospital - Saginaw
North Carolina
- Ortho Carolina Research Institute - Charlotte
Oklahoma
- SSM Health Bone and Joint Hospital at St. Anthony - Oklahoma City
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-10-26 |
| Est. Completion | 2020-08-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03721328
The ClinicalTrials.gov registry entry for NCT03721328 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 9 other Prosthetic-joint Infection trials with a reported enrollment target (85% lower). The listed sponsor is Osteal Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prosthetic-joint Infection appearing as the primary indexed condition, and to 1 intervention - of which vancomycin hydrochloride and tobramycin sulfate is the first listed.
NCT03721328 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Michigan, North Carolina, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT03721328 about?
NCT03721328 is a clinical study titled "Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation". Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI. Primary Outcome Measure The overall safety profile is ...
What is the current status of trial NCT03721328?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2018-10-26. Estimated completion is 2020-08-25.
What conditions does trial NCT03721328 study?
This clinical trial studies the following conditions: Prosthetic-joint Infection.
What interventions are being tested in trial NCT03721328?
The interventions under investigation include: vancomycin hydrochloride and tobramycin sulfate (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03721328?
This trial is sponsored by Osteal Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03721328 being conducted?
This trial has 4 study locations across Michigan, North Carolina, Oklahoma, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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