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  • Detection of Infection in Arthroplasty Rochester, Minn.

    The purpose of this study is to determine the sensitivity, specificity, positive and negative predictive values of molecular detection of microorganisms, detection of microbial proteins and antibodies against microorganisms, and inflammatory markers (e.g., leukocyte esterase, CRP) in synovial fluid for the diagnosis of prosthetic joint infection (PJI).

Closed for Enrollment

  • Clinical and Economic Impact of a Rapid Rest for Detection of Methicillin-resistant Staphylococcus Aureus (MRSA) from Sterile Sites (the Alere™ PBP2a) Rochester, Minn.

    The objective of this study is to evaluate the impact of the Alere™ PBP2a test combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in hospitalized patients with sterile site S. aureus infection.

  • Clinical Validation of CD Diagnostics Synovasure® PJI ELISA Test and Synovasure® PJI Lateral Flow Test For Detection of Periprosthetic Joint Infection (PJI) in Synovial Fluid (MVSS CDD02-15 PJI) Scottsdale/Phoenix, Ariz., Rochester, Minn.

    The purpose of this study is to demonstrate the tests' performance when compared to the detection of periprosthetic joint infection (PJI) using the Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for diagnosing PJI. This criteria-based definition of PJI places emphasis on culture techniques that identify pathogens, but also provides for minor criteria that can be used to diagnose PJI. This study will also calculate the tests' clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV).

  • Detection and Identification of Bacterial and Fungal DNA in Blood Rochester, Minn.

    This study includes collection of blood samples from the healthy controls and those with suspected bloodstream infections.

  • Detection of Microorganisms and Antibiotic Resistance Genes in Lower Respiratory Tract (LRT) Samples, Using the Curetis UnyveroTM LRT55 Application Rochester, Minn.

    The Curetis Unyvero LRT55 Application is intended to detect and to identify genes of 21 microorganisms and 19 genes associated with antibiotic resistance in 4 hours.

    In this study, the performance of the Unyvero LRT55 Application shall be tested under clinical conditions and compared to (1) a composite reference method (for non-atypical or cultured microorganisms) or (2) a molecular PCR based reference method for the 3 atypical microorganisms Chlamydophila pneumoniae, Legionella pneumoniae, and Pneumocystis jirovecii, and for resistance genes.

    PCR amplifications are followed by bi-directional sequencing, including comparison of the test results Time to result will be compared for the Unyvero LRT55 Application and standard-of care.

  • Fusobacterium Necrophorum Pharyngitis Rochester, Minn.

    The purpose of this study is to determine the number of de-identified discard throat swabs submitted for testing for group A streptococcus that are positive for Fusobacterium necrophorum.  Determine the number of anonymously self-collected throat swabs from normal volunteers that are positive for F. necrophorum.

  • Mayo Clinic COVID-19 Pandemic Response Biobank of Clinical Residual Samples Scottsdale/Phoenix, Ariz., Rochester, Minn., Jacksonville, Fla.

    This Research Repository will prospectively collect residual (waste) blood, urine, and stool specimens remaining from clinician order testing and corresponding clinical and patient provided data from COVID-19 patients with confirmed or suspected infection with the novel SARS-CoV-2 virus to enable high quality research.  Participants will be approached for consent by the study team after the samples are identified. Samples and data from this repository will be made available to researchers with IRB-approved research projects after review and approval by the COVID-19 Access Committee.  We believe this biobank will enable high quality research to improve clinical practice and patient outcomes.

    Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Participation in this Research Repository is by invitation only. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. 


  • Metagenomic Analysis of Blood and Urine for Microbial Pathogen Discovery and Undiagnosed Infection Rochester, Minn.

    The aim of this study is to identify difficult to diagnose microbial pathogens causing infections using blood or urine for identification of bacteria, viruses, fungi or parasites that are not detectable or are difficult to detect using current diagnostic techniques.

  • Metagenomic Shotgun Sequencing of Blood to Identify Pathogens in Patients with Neutropenic Fever Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to determine whether metagenomic shotgun sequencing can identify microorganisms present in blood sample of patients with febrile neutropenia. 

  • Ureaplasma Species and Hyperammonemia in Neonates Rochester, Minn.

    This study will compare plasma ammonia levels among neonates with and without Ureaplasma colonization of their respiratory tract. It will compare neonates with and without Ureaplasma colonization to identify differences in clinical characteristics, including gestational age, mode of delivery, comorbidities, and clinical status. It will also compare neonates with and without hyperammonemia to identify differences in clinical characteristics, including gestational age, mode of delivery, comorbidities, and clinical status.

  • Whipple's Disease: The Diagnostic Utility of Synovial Fluid Tropheryma Whipplei PCR Rochester, Minn.

    The purpose of this study is to determine diagnostic usefulness by comparing the rate of positive synovial fluid T. whipplei PCR tests, with the clinical characteristics and outcomes of patients who have Whipple's disease.