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

Study Title:  A Phase 3, Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Rebiotix RBX2660 (microbiota suspension) for the Prevention of Recurrent Clostridium difficile Infection

  • Study Type: Phase 3, double-blinded
  • Purpose: To confirm the efficacy and safety of the study drug in preventing reccurent Clostridium difficile.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Yasmeen Rezaishad —ph: 916-734-8101 email: yarezaishad@ucdavis.edu

Study TitleA Phase 3 Multicenter, RandomizeEd, Double Blind, -Placebo Controlled, -Parallel Group- Study to Evaluate the Safety, Tolerability, and Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium difficile Infection (CDI) in Adults Who Have Received Antibacterial Drug Treatment for Recurrent CDI (RCDI)

  • Study Type: Phase 3, double-blinded
  • Purpose: To demonstrate the safety and efficacy of the study drug in reducing Clostridium difficile infection (CDI) recurrence rates.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Lena Stashko —ph: 916-734-5174 email: lastashko@ucdavis.edu

Study TitleAn Open-Label Extension of Study SERES 0012 Evaluating SER-109 in Subjects With Recurrent Clostridium Difficile Infection

  • Study Type: Phase 3, open-label
  • Purpose: The purpose of this study is to assess safety and efficacy of the study drug in reducing recurrence of Clostridium difficile infection (CDI) in adults who had a CDI recurrence in parent study.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Lena Stashko —ph: 916-734-5174 email: lastashko@ucdavis.edu

Study TitleA 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)

  • Study Type: Phase 3, double-blinded
  • 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: Yasmeen Rezaishad —ph: 916-734-8101 email: yarezaishad@ucdavis.edu

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

  • Study Type: Phase 3, double-blinded
  • Purpose: To prevent CMV disease in donor positive, recipient negative kidney transplant recipients.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Lena Stashko —ph: 916-734-5176 email: lastashko@ucdavis.edu

Study Title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients with Cytomegalovirus (CMV) Infections that are Refractory or Resistant to Treatment with Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

  • Study Type: Phase 3, open-label
  • Purpose: To compare the efficacy of study drug to standard of care on CMV viremia clearance and tissue-invasive CMV disease.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Kate Trigg —ph: 916-734-8033 email: ktrigg@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

  • Study Type: Phase 3, double-blind
  • 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: Kate Trigg —ph: 916-734-8033 email: ktrigg@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

  • Study Type: Open-label
  • 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: Yasmeen Rezaishad —ph: 916-734-8101 email: yarezaishad@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

  • Study Type: Phase 2, open label
  • 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: Kate Trigg —ph: 916-734-8033 email: ktrigg@ucdavis.edu

Study Title: An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non Neutropenic Patients With Candidemia, With or Without Invasive Candidiasis, Inclusive of Patients With Suspected Resistance to Standard of Care Antifungal Treatment

  • Study Type: Open label
  • Purpose: The purpose of this study is to determine the efficacy and safety of APX001 in patients with candidemia at the end of study treatment.
  • Principal Investigator: George Thompson, M.D.
  • Study Contact: Lena Stashko —ph: 916-734-5176 email: lastashko@ucdavis.edu

Study Title: A Comparative Study to Evaluate Dual Amplification PCR Testing (MYCODART-PCR) of 6 Candida species in Patients with Documented Candidemia/Invasive Candidiasis

  • Study Type: Device
  • Purpose: The purpose of this study is to compare the sensitivity and specificity of the MYCODART-PCR Candida Panel vs blood culture in detecting Candida spp.
  • Principal Investigator: George Thompson, M.D.
  • Study Contact: Kate Trigg —ph: 916-734-8033 email: ktrigg@ucdavis.edu

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

Study Title: Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination With Systemic Antibiotics in the Treatment of Catheter-Related or Central Line-Associated Bloodstream Infection

  • Study Type: Phase 3, open label
  • Purpose: The primary objective of this study is to determine efficacy and safety for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI).
  • Principal Investigator: Hien Nguyen, M.D.
  • Study Contact: Yasmeen Rezaishad —ph: 916-734-8101 email: yarezaishad@ucdavis.edu

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

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: Investigational

  • Purpose: To demonstrate safety and efficacy of DAS181 in treatment of PIV in immunompromised patients.
  • Principal Investigator: Stuart Cohen, M.D.

 

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

Study Type: Investigational

  • 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 Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection

Study Type: Investigational

  • Purpose: To evaluate the superiority of pimodivir compared to standard of care in treating hospitalized influenza A infection.
  • Principal Investigator: Hien Nguyen, M.D.

 

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

Study Type: Investigational

  • Purpose: To evaluate the safety and tolerability of SUBA-itraconazole in treating endemic mycoses.
  • Principal Investigator: George Thompson, M.D.

 

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)

Study Type: Investigational

  • Purpose: To evaluate the efficacy of letermovir versus placebo in extending prophylaxis treatment in post-transplant recipients.
  • Principal Investigator: Stuart Cohen, M.D.

 

Study Title: A PROSPECTIVE, RANDOMIZED, OPEN-LABEL, COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) AND BEST AVAILABLE THERAPY FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO-Β-LACTAMASE (MBL)

Study Type: Investigational

  • Purpose: To evaluate the efficacy of ATM-AVI in treating serious MBL-producing gram-negative bacteria.
  • Principal Investigator: Hien Nguyen, M.D.

 

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

Study Type: Investigational

  • Purpose: To evaluate the safety and tolerability of coadministration of SCY-078 and voriconazole compared to monotherapy in treating invasive pulomany aspergillosis.
  • Principal Investigator: George Thompson, M.D.