Clinical Research in Infectious Diseases

Clinical research (research involving human subjects) may include the evaluation of therapies, treatments, devices, medications, surgeries, and/or diagnostic tools. The results from clinical research advance the efficacy and safety of new treatments and directly improve patient care and quality of life.

The Division of Infectious Diseases has a research team whom coordinates all clinical research with the Infectious Diseases clinical faculty. In addition to clinical research, the faculty members conduct laboratory research both at the UC Davis Medical Center and on the UC Davis Campus. 

Each type of clinical research plays an integral part in strengthening our knowledge of certain diseases or conditions. With clinical research, we can implement better techniques to diagnose, treat, and prevent human diseases and conditions.

Clinical Trials

The majority of clinical research consists of clinical trials, which may be sponsored or funded by physicians, foundations, federal health agencies (such as the National Institutes of Health), pharmaceutical companies, or university grants.

A clinical trial is a study that looks for new ways to prevent, detect, diagnose, and/or treat a disease or condition. Clinical trials are research projects that have two main objectives in mind: patient safety and disease treatment/prevention. Patients are at the forefront of medicine when they choose to be a participant in a clinical trial. Not only are they contributing to the medical and scientific understanding of their disease, but they also have access to the newest treatments.

Observational Study

This type of study observes people or specific outcomes are measured and recorded. Clinical data is typically only collected and there isn’t any experimental treatment. Another term for these types of studies are retrospective reviews or registry study. 

These studies help us understand specific diseases and to identify any causal relationships. Participating in these studies provide important information that has the possibility to help future patients.

Basic Research

These studies collect biological samples from volunteers who are either healthy or suffer from a specific condition. Subjects typically do not directly benefit from participation but their participation has the possibility to help future patients.

Clinical research studies are very different from regular medical care. Your primary care physician will diagnose and treat you for an illness or condition. Clinical researchers gather new information to help improve future medical care.

For additional information, contact the research team at hs-IDresearch@ucdavis.edu

Clostridium difficile

Study Title: A Phase 3, Randomized, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Ridinilazole (200 mg, Bid) for 10 Days With Vancomycin (125 mg, Qid) for 10 Days in the Treatment of Clostridium Difficile Infection (CDI)

  • Nickname: RiCoDIFy
  • Purpose: To confirm the efficacy and safety of ridinilazole in treating Clostridium difficile within 30 days after the end of treatment.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Dean Boswell —ph: 916-734-8101 email: dboswell@ucdavis.edu

Study Title: A Double-Blind Placebo-Controlled Phase 2 Study of VE303 for Prevention of Recurrent Clostridium (Clostridioides) Difficile Infection

  • Nickname: CONSORTIUM
  • Purpose: To evaluate the efficacy and safety of VE303 in preventing recurrent Clostridium difficile compared to standard of care.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Olivia Smith —ph: 916-734-3339 email: ojsmith@ucdavis.edu

Study Title: An Exploratory, Open-Label, Oligo-Center Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravenous DNV3837 in Subjects with Clostridium difficile Infection

  • Study Type: Investigational
  • Purpose: To evaluate the safety and efficacy of IV study drug, DNV3837, in treatment of patients with CDI compared to standard of care.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Nicole Garza -- ph: 916-734-1632, email: ngarza@ucdavis.edu

COVID-19

Study Title: Adaptive COVID-19 Treatment Trial (ACTT)

  • Nickname: ACTT
  • Purpose: The primary endpoint of this study is to determine whether remdesivir improves days to recovery when compared to placebo for the treatment of COVID-19 infection.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Melina Sneesby —ph: 916-734-5176 email: msneesby@ucdavis.edu

Study Title: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)

  • kname: ACTIV-2
  • Purpose: To determine the safety and efficacy of the study drug to o reduce the duration of COVID-19 symptoms through study day 28.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Olivia Smith —ph: 916-734-1633 email: ojsmith@ucdavis.edu

Study Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects with Moderate COVID-19

  • Nickname: AT-527
  • Purpose: The primary objective is to show improvement of respiratory function by a 2 point improvement (increase) in the Ordinal Scale from baseline when compared to placebo for the treatment of COVID-19 infection.
  • Principal Investigator: George Thompson, MD
  • Study Contact: Dean Boswell —ph: 916-734-8330 email: mkahil@ucdavis.edu

Study Title: A PHASE I/II STUDY OF HUMAN PLACENTAL HEMATOPOIETIC STEM CELL DERIVED NATURAL KILLER CELLS (CYNK-001) FOR THE TREATMENT OF ADULTS WITH COVID-19

  • Nickname: CYNK
  • Purpose: The primary objective is to demonstrate minimal adverse events and show effective clearance of SARS-CoV-2 infection.
  • Principal Investigator: Stuart Cohen, MD & Mehrdad Abedi, MD
  • Study Contact: Olivia Smith —ph: 916-734-3339 email: ojsmith@ucdavis.edu

    Study Title: A Phase 3, Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting

    • Nickname: 540-9012
    • Purpose: The primary objective is to determine the efficacy of remdesivir (RDV) in reducing the rate of hospitalization or death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting
    • Principal Investigator: George Thompson, MD
    • Study Contact: Gursimran Mann —ph: 916-734-1633 email: gsmmann@ucdavis.edu

      Study Title: A Phase 1b/2a Study in Participants with Early Stage COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation

      • Nickname: 553-9020
      • Purpose: The primary objective is to characterize the impact of inhaled remdesivir on COVID-19 viral load in participants with early stage disease and to evaluate the safety of RDV administered in an outpatient setting.
      • Principal Investigator: Stuart Cohen, MD
      • Study Contact: Cheo Vazquez —ph: 916-734-0130 email: etvazquez@ucdavis.edu

        Study Title:A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Hospitalized Adults with COVID-19

        • Nickname: 4482-001
        • Purpose: The primary objective is to evaluate the safety, tolerability and efficacy of molnupiravir (MK4482) and prove it's superior to placebo.
        • Principal Investigator: George Thompson, MD
        • Study Contact: Gursimran Mann—ph: 916-734-1633 email: gsmmann@ucdavis.edu

          Study Title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK4482 in non-Hospitalized Adults With COVID-19.

          • Nickname: 4482-002
          • Purpose: The primary objective is to evaluate the safety, tolerability and efficacy of molnupiravir (MK4482) and prove it's superior to placebo.
          • Principal Investigator: George Thompson, MD
          • Study Contact: Nicole Garza —ph: 916-734-1632 email: ngarza@ucdavis.edu

          Study Title: A Phase II/III randomized, multi-center, double-blind, placebo-controlled study to assess the safety and efficacy of monoclonal antibody VIR-7831 for the early treatment of coronavirus disease 2019 (COVID-19) in nonhospitalized patients.

          • Nickname: COMET-ICE
          • Purpose: The primary objective is to evaluate the efficacy of the study drug versus placebo in preventing the progression of mild/moderate COVID-19.
          • Principal Investigator: George Thompson, MD
          • Study Contact: Melina Sneesby —ph: 916-734-5176 email: msneesby@ucdavis.edu

          COVID-19 prevention

          Study Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2

          • Nickname: REGN COV2069
          • Purpose: The primary objective is to evaluate the efficacy of study drug compared to placebo in preventing SARS-CoV-2 infection.
          • Principal Investigator: Stuart Cohen, MD
          • Study Contact: Cheo Vazquez —ph: 916-734-0130 email: atvazquez@ucdavis.edu

          Study Title: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant in Adult Participants ≥ 18 Years (THIS STUDY IS NO LONGER RECRUITING AND IS IN FOLLOW UP ONLY)

          • Nickname: 2019nCOV-301
          • Purpose: The primary objective is to evaluate the efficacy of study drug compared to placebo in preventing SARS-CoV-2 infection.
          • Principal Investigator: Stuart Cohen, MD
          • Study Contact: hs-novavax@ucdavis.edu

          Cytomegalovirus

          Study Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients

          • Nickname: Let 002
          • Purpose: To prevent CMV disease in donor positive, recipient negative kidney transplant recipients.
          • Principal Investigator: Stuart Cohen, M.D.
          • Study Contact: Olivia Smith — ph: 916-734-1633; email: ojsmith@ucdavis.edu

          Study Title: A Phase 3 randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of letermovir (LET) prophylaxis when extended from 100 days to 200 days post-transplant in cytomegalovirus (CMV) seropositive recipients (R+) of an allogenic hematopoietic stem cell transplant (HSCT)

          • Nickname: Let Ext 040
          • Purpose: To evaluate the efficacy of letermovir versus placebo in extending prophylaxis treatment in post-transplant recipients.
          • Principal Investigator: Stuart Cohen, M.D.
          • Study Contact: Melina Sneesby —ph: 916-734-5176 email: msneesby@ucdavis.edu

          Fungal Infections

          Study Title:A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of APX001 in the Treatment of Patients with Invasive Mold Infections Caused by Aspergillus Species or Rare Molds

          • Purpose: To assess the safety and efficacy of study drug in treating patients with rare invasive mold infections.
          • Principal Investigator: Stuart Cohen, MD
          • Study Contact: Mohamad Kahil —ph: 916-734-8330 email: mkahil@ucdavis.edu

          Study Title: A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

          • Nickname: ReSTORE
          • Purpose: The purpose of this study is to evaluate the safety, tolerability and overall success of CD101 in subjects with candidemia and/or invasive candidiasis. 
          • Principal Investigator: George Thompson, M.D.
          • Study Contact: Mohamad Kahil —ph: 916-734-8330 email: mkahil@ucdavis.edu

          Study Title: Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients with Fungal Diseases that are Refractory to or Intolerant of Standard Antifungal Treatment

          • Nickname: FURI
          • Purpose: The purpose of this study is to evaluate the safety and efficacy of the study drug by assessing global success at the end of treatment. 
          • Principal Investigator: George Thompson, M.D.
          • Study Contact: Hana Minsky —ph: 916-734-8036 email: hbminsky@ucdavis.edu

          Study Title: Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options

          • Nickname: FORMULA
          • Purpose: The purpose of this study is to determine overall response to F901318 at Day 42 using clinical, mycological and radiological response.
          • Principal Investigator: George Thompson, M.D.
          • Study Contact: Yasmeen Rezaishad —ph: 916-734-8101 email: yarezaishad@ucdavis.edu

          Study Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Coadministration of SCY-078 with Voriconazole in Patients with Invasive Pulmonary Aspergillosis (SCYNERGIA)

          • Nickname: SCYNERGIA
          • Purpose: The purpose of this study is to evaluate the safety, tolerability and overall success of SCY-078 when coadministered with voriconazole in subjects with invasive pulmonary aspergillosis. 
          • Principal Investigator: George Thompson, M.D.
          • Study Contact: Mohamad Kahil —ph: 916-734-8330 email: mkahil@ucdavis.edu

          Study Title:  SUBA-itraconazole versus conventional itraconazole in the treatment of endemic mycoses: a multi-center, open-label, randomized, comparative trial 

          • Nickname: MSG-15
          • Purpose: To evaluate the safety and tolerability of SUBA-itraconazole in treating endemic mycoses.
          • Principal Investigator: George Thompson, M.D.
          • Study Contact: Melina Sneesby —ph: 916-734-5176 email: msneesby@ucdavis.edu

          HIV

          Study Title: A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are at Risk of HIV-1 Infection

          • Study Type: Phase 3, double-blind
          • Purpose: To see if F/TAF is safe and effective for use as pre-exposure Prophylaxis (to prevent) or PrEP to prevent HIV-1 infection in healthy adults.
          • Principal Investigator: David Asmuth, M.D.
          • Study Contacts: Tammy Yotter, RN at 916-914-6261

          Study Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects who are Virologically Suppressed

          • Study Type: Phase 3, double-blind
          • Principal Investigator: Richard Pollard, M.D.
          • Study Contact: Tammy Yotter, RN at 916-914-6261

          Mycobacterial infections

          Study Title: Compassionate Use of Clofazimine for the Treatment of Mycobacterium Infections

          • Study Type: Investigational
          • Purpose: To provide compassionate use access to clofazimine to patients with mycobacterial infections.
          • Principal Investigator: Stuart Cohen, M.D.
          • Study Contact: Kate Trigg —ph: 916-734-8033 email: ktrigg@ucdavis.edu

          Infections in Immunocompromised Patients

          Study Title: A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS 181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

          • Study Type: Phase 3
          • Purpose: To demonstrate safety and efficacy of DAS181 in treatment of PIV in immunompromised patients.
          • Principal Investigator: Stuart Cohen, M.D.
          • Study Contact: Nicole Garza —ph: 916-734-1632 email: ngarza@ucdavis.edu

          Study Title: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF THE SAFETY, TOLERABILITY, AND EFFICACY OF RV521 IN THE TREATMENT OF ADULT SUBJECTS WHO HAVE UNDERGONE HEMATOPOIETIC CELL TRANSPLANTATION (HCT) WITH A DOCUMENTED UPPER RESPIRATORY TRACT INFECTION (URTI) WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)

          • Purpose: To assess the safety and tolerability of study drug in treating immunocompromised patients with respiratory syncytial virus infections of their upper respiratory tract. 
          • Principal Investigator: Stuart Cohen, M.D. 
          • Study Contact: Nicole Garza —ph: 916-734-1632 email: ngarza@ucdavis.edu

          Study Title: A randomized, open label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised adults

          • Purpose: To assess the safety and efficacy of pritelivir in treating immunocompromised patients with acyclovir-resistant HSV infection.
          • Principal Investigator: Stuart Cohen, M.D.
          • Study Contact: Nicole Garza —ph: 916-734-1632 email: ngarza@ucdavis.edu

          Skin & Soft Tissue Infections

          Study Title: Randomized Open-label Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of Afabicin IV/oral in the Treatment of Patients with Bone or Joint Infection due to Staphylococcus

          • Purpose: To assess the safety and tolerability of afabicin in treatment of patients with bone or join infections compared to standard of care.
          • Principal Investigator: Hien Nguyen, M.D.
          • Study Contact: Mohamad Kahil —ph: 916-734-8330 email: mkahil@ucdavis.edu

          Upcoming studies

          Study Title: Industry Alliance Platform Trial to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients

          • Purpose: To assess the safety and effectiveness of various study drugs in hospitalized patients with COVID-19.
          • Principal Investigator: Stuart Cohen, MD

          Study Title: SUBA™-Itraconazole Therapy for Coccidioidomycosis Refractory or Intolerant to Fluconazole

          • Purpose: To assess the efficacy of SUBA™-Itraconazole for cocci infection
          • Principal Investigator: George Thompson, M.D. 

          Study Title: Invasive Aspergillosis Complicating Severe Influenza

          • Purpose: To examine co-infection of aspergillosis with severe influenza
          • Principal Investigator: George Thompson, M.D. 

          Study Title: Dalbavancin as an Option for Treatment of S. aureus Bacteremia (DOTS): A Phase 2b, Multicenter, Randomized, Open-Label, Assessor-Blinded Superiority Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients with Complicated S. aureus Bacteremia

          • Purpose: To compare the Desirability of Outcome Ranking (DOOR) at Day 70 of dalbavancin to that of standard of care for the treatment of subjects with complicated S. aureus bacteremia in the intent-to-treat (ITT) population.
          • Principal Investigator: George Thompson, M.D. 

          Study Title: COVID-19 associated pulmonary aspergillosis (CAPA) and other invasive fungal infections (IFI)

          • Nickname: MSG-17
          • Purpose: To examine co-infection of COVID-19 with invasive fungal infections.
          • Principal Investigator: George Thompson, M.D. 

          Study Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, COMPARATOR-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CRS3123 COMPARED WITH ORAL VANCOMYCIN IN ADULTS WITH CLOSTRIDIOIDES DIFFICILE INFECTION

          • Purpose: The primary objectives of the study are the evaluation of safety and efficacy (rate of clinical cure at end of treatment in the intent-to-treat population.
          • Principal Investigator: Stuart Cohen, M.D.