Infectious Diseases Research

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. A Study to Evaluate the Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridium Difficile Infection

   Rochester, Minn.

   The purpose of this study is to characterize mucosal and luminal microbiome in patients diagnosed with Clostridium difficile infection (CDI), at the time of diagnosis and after treatment, to determine the effect of mucosa associated microbiome on outcome of CDI and the effect of antibiotic treatment on mucosa associated microbiome

2. ECOSPOR IV: An Open-Label Extension of Study SERES 0012 Evaluating SER-109 in Subjects With Recurrent Clostridium Difficile Infection

   Rochester, Minn.

   Subjects who had a CDI recurrence in Study SERES-012 within 8 weeks of receipt of study drug will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to assess safety and efficacy of SER-109 in reducing recurrence of Clostridium difficile infection (CDI) in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in Study SERES-012.

3. A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate the safety and efficacy of ABT-493 and ABT-530 (or ABT-493/ABT-530) coadministered with and without ribavirin in adults with chronic HCV genotypes 2, 3, 4, 5 or 6 infection. In part 4, the primary objectives also include to assess the efficacy (SVR12) of treatment with ABT-493/ABT-530 combination regimen in GT2-infected DAA-naive subjects without cirrhosis compared to historical SVR12 rate of treatment with sofosbuvir plus RBV in GT2-infected DAA-naive subjects without cirrhosis.

4. SURPASS: A Randomized, Double-Blind, Multicenter Study of the Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus (CMV) Disease in CMV Seropositive Kidney Transplant Recipients

   Rochester, Minn.

   The purpose of this study is to compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of CMV disease in kidney transplant recipients who are CMV seropositive pretransplant and received antilymphocyte induction therapy.

5. A Study to Assess the Utility of Cell Count and Differential of Aspirated Fluid in the Diagnosis of Native Vertebral Osteomyelitis

   Rochester, Minn.

   The purpose of this study is to assess the utility of cell count and differential from aspirated fluid obtained via CT guided needle aspiration biopsy of vertebral bone and intervertebral disc space in the diagnosis of native vertebral osteomyelitis (NVO).

6. A Study to Evaluate Biomarkers of Fluoroquinolone-induced Mitochondrial Toxicity

   Rochester, Minn.

   The purposes of this study are to determine if patients treated with fluoroquinolone (FQ) antibiotics have depletion of mitochondrial DNA (mtDNA) in buccal swab samples, and whether the degree of depletion correlates with the likelihood of developing FQ-associated toxicity.

   2nd arm - An additional group of patients will be enrolled if they previously received FQ antibiotics. appear to be symptomatic and have a previously collected muscle or nerve biopsy for clinical purposes available for this research study. 

7. A Study To Evaluate the Effectiveness, Safety, And Tolerability of a Clostridium Difficile Vaccine In Adults 50 Years of Age and Older

   Rochester, Minn.

   The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

8. Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea

   Scottsdale/Phoenix, Ariz.

   This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.

9. Study for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

   Rochester, Minn.

   The purpose of this study is to compare the efficacy and safety of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant recipients.

10. A Study to Establish An Integrated Biomarker Panel for COVID-19 Infection Risk and Severity Prediction

    Rochester, Minn., Jacksonville, Fla.

    Aim 1: Determine the basal profile of non-genomic factors in patients at the time of exposure to SARS-CoV-2 and correlate with the three clinical patient outcome categories (A, B, C) as observed through their clinical course. 

    Hypothesis: Baseline cytokine (IL-1β, IL-6, IL-4, IL-10, IFN-g and TNF-a) and the immune cellular repertoire (helper/CD4+, cytotoxic/CD8+, T-regulatory cells, natural killer cells) constitute the inherent biologic immunity of an individual and underpins their vulnerability to SARS-CoV-2 infectivity and/or its subsequent sequalae. 

    Aim 2: Investigate if mutations or polymorphisms in genes (CXCR6, ACE2 and SLC6A20) linked to SARS-CoV-2 correlates with the three clinical patient outcome categories (A, B, C) as observed through their clinical course.

    Hypothesis: ACE2 is a cellular receptor for SARS-CoV-2. The high binding affinity of ACE2 to SARS-CoV-2 is determined by its gene sequence and polymorphisms in the ACE2 gene itself or those that regulate ACE2 function (i.e. SLC6A20) can alter this binding potential and thus the clinical impact of the virus. 

    Aim 3:  Develop an integrated model of non-genomic (Aim 1) and genomic (Aim 2) factors for prediction of the three potential clinical courses of an individual upon exposure to SARS-CoV-2.  

    Hypothesis:  An integrated model incorporating quantitative analysis of cytokines/immune cells (Aim 1) and gene sequence analysis (Aim 2) will allow a more robust and accurate prediction for one of the three potential clinical courses (A, B, C) after SARS-CoV-2 exposure.