This study is currently not recruiting participants.

"Collection of Samples for the Development and Validation of the Unyvero Invasive Joint Infection (IJI) Application"

Investigation of Synovial Fluid Samples for Joint Infections

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

This sample collection study will be a multi-center competitive enrollment, non-interventional study conducted at three or more institutions in the United States and/or around the world. The study will use residual synovial fluid samples takes from subjects suspected with invasive joint infections (IJI). This will include samples collected from the native or prosthetic joints. The study will collect synovial fluid samples that are confirmed positive for one or more IJI panel microorganisms as well as a defined number of samples negative for infection. These samples would otherwise be discarded after clinical testing for patient care.

Samples will be collected, de-identified and frozen at the clinical sites and batch shipped to the Sponsor for testing. Additionally, samples will be tested at IU under a different protocol in the future.

Detailed description of study

This sample collection study will be a multi-center competitive enrollment, non-interventional study conducted at three or more institutions in the United States and/or around the world. The study will use residual synovial fluid samples takes from subjects suspected with invasive joint infections (IJI). This will include samples collected from the native or prosthetic joints. The study will collect synovial fluid samples that are confirmed positive for one or more IJI panel microorganisms as well as a defined number of samples negative for infection. These samples would otherwise be discarded after clinical testing for patient care.

Samples will be collected, de-identified and frozen at the clinical sites and batch shipped to the Sponsor for testing. Additionally, samples will be tested at IU under a different protocol in the future.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Unyvero Invasive Joint Infection
  • Age: 100 years or below
  • Gender: All

This study investigates synovial fluid samples from people suspected of having invasive joint infections. Invasive joint infections are serious infections that can affect the joints, and synovial fluid is a liquid found in the joints that helps them move smoothly. The purpose of the study is to collect synovial fluid samples that test positive for certain microorganisms related to these infections, as well as some samples that do not show infection.

In this study, synovial fluid samples that would normally be discarded after routine clinical tests will be collected, de-identified, and frozen at various clinical sites. These samples will then be sent in batches to the sponsor for further testing. In the future, additional testing will be conducted at a university under a different protocol.

  • Who can participate: Individuals undergoing joint fluid collection for suspected infections are eligible for sample inclusion in this study.
  • Study details: Participants will not need to take any specific actions as this is a non-interventional study. Synovial fluid samples already collected during routine care will be used.
Updated on 19 Feb 2024. Study ID: 1801764899

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