Clinical Research in Infectious Diseases

Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial has now been published in The Lancet

Click Here for the Article 

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

Infectious Disease Student Assistant Researcher Program

The Infectious Disease Student Assistant Researcher Program (IDStAR) is a unique opportunity for undergraduate students to learn about clinical research and healthcare within Infectious Diseases. IDStAR is a volunteer program and is developed from the established, EMRAP program in Emergency Medicine.

IDStAR supports the ongoing clinical and epidemiological research within the Department of Internal Medicine.  Working in IDStAR affords the opportunity to find out whether students will enjoy working within medicine, clinical research or an ancillary health care profession.

Volunteering as a Student Researcher, gives students the opportunity to come to clinics with faculty, observe operations of units and services across the hospital, learn from clinical research staff, nurses and other team members impacted by clinical research. 

What you might take away from this opportunity:

  • Learning hospital systems and operations
  • Working with infectious disease faculty
  • Learning medical terminology
  • Collecting and processing samples
  • Learning about signs and symptoms of diseases
  • Conducting surveys or performing assessment

Upon completion, outstanding volunteers can expect to receive letters of recommendation for excellent service. 

Bacteremia

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 Contact: Nicole Garza -- ph: 916-734-1632, email: ngarza@ucdavis.edu

Clostridium difficile

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: Jaimie Figueroa -- ph: 916-734-5384, email: jkfigueroa@ucdavis.edu

Study Title: Ibezapolstat (ACX-362E) for Oral Treatment of Clostridioides difficile Infection: A Phase 2A Open-Label Segment Followed by a Phase 2B Double-Blind Vancomycin-Controlled Segment

  • Study Type: Investigational
  • Purpose: To evaluate the safety and efficacy of oral study drug, ACX-362E, in treatment of patients with primary CDI compared to standard of care.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Trina Reynolds -- ph: 916-734-6384, email: tlreynolds@ucdavis.edu

COVID-19

UPCOMING Study Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment
of COVID-19 in Nonhospitalized Participants

  • Nickname: Oaktree
  • Purpose: The primary objective is to demonstrate safety and efficacy of GS-5245 in outpatients with COVID-19 infection.
  • Principal Investigator: Stuart Cohen, M.D.

UPCOMING Study Title: (AT-03A-017) A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients with COVID-19

  • Nickname: SUNRISE-3
  • Purpose: The primary objective is to demonstrate safety and efficacy of Bemnifosbuvir in high-risk outpatients with COVID-19 infection.
  • Principal Investigator: Stuart Cohen, M.D.

COVID-19 prevention

UPCOMING Study Title: A Phase I/III Randomized, Double-blind Study to Evaluate the Safety and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants with Conditions Causing Immune Impairment

  • Nickname: SUPERNOVA
  • Purpose: The primary objective is to bridge the established safety and efficacy of AZD7442 (EVUSHELD™) for the pre-exposure prophylaxis of COVID-19.
  • Principal Investigator: Alan Koff, M.D.
  • Study Contact: Ryan Ciuffetelli; rcuiffetelli@ucdavis.edu

Cytomegalovirus

UPCOMING: CMV in immunocompromised patients

Fungal Infections

Study Title: A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin followed by Oral Ibrexafungerp versus Intravenous Echinocandin followed by Oral Fluconazole 

Study Title: A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species

  • Nickname: OASIS
  • Purpose: The purpose of this study is to compare all-cause mortality (ACM) at Day 42 following treatment with olorofim versus treatment with AmBisome®.
  • Principal Investigator: George Thompson, M.D.
  • Study Contact: Ryan Ciuffetelli —ph: 916-734-8101 email: rciuffetelli@ucdavis.edu

Study Title: Invasive Aspergillosis Complicating Severe Influenza

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

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: Vera Go, 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: Vera Go, 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

  • Purpose: To provide compassionate use access to clofazimine to patients with mycobacterial infections.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Ivy Tou —ph: 916-734-8330 email: itou@ucdavis.edu

UPCOMING Study Title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Study to Assess the Efficacy, Safety, and Pharmacokinetics of Orally Administered Epetraborole in Patients with Treatment-refractory Mycobacterium avium Complex Lung
Disease (MACrO2)

  • Study Type: Investigational
  • Purpose: To provide compassionate use access to clofazimine to patients with mycobacterial infections.
  • Principal Investigator: Stuart Cohen, M.D.

Hepatitis

Study Title: A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB
8-Week Treatment in Adults and Adolescents with Acute Hepatitis C Virus (HCV) Infection

Monkeypox

Study Title: A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease (STOMP)

  • Purpose: To compare the efficacy between tecovirimat versus placebo
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Kenzie Usher — email: kcusher@ucdavis.edu

Study Title: Expanded Access of Tecovirimat (TPOXX) for the treatment of monkeypox

  • Purpose: To provide compassionate use access to TPOXX to patients with monkeypox.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Ivy Tou —ph: 916-734-8330 email: itou@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: Jacob Monares —ph: 916-734-8802 email: jmonares@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: Christine Gichigi —ph: 916-734-6942 email: cwgichigi@ucdavis.edu

Pneumonia

UPCOMING Study Title: Reparixin 1200 mg three times a day as add-on therapy to standard of care to limit disease progression in hospitalised adult patients with COVID-19 and other community-acquired pneumonia.

  • Nickname: REPAVID-22
  • Principal Investigator: Hien Nguyen, M.D.
  • Study Contact: Jaimie Figueroa -- ph: 916-734-5384, email: jkfigueroa@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: Nicole Garza —ph: 916-734-1632 email: ngarza@ucdavis.edu

Surgical Site Infections

Study Title: Decolonization to Reduce After-Surgery Events of Surgical Site Infection (DECREASE) SSI Trial

  • Purpose: To reduce post-discharge surgical site infection following open colon or small bowel surgery by comparing chlorhexidine bathing plus nasal mupirocin to soap without antiseptic properties (placebo) and placebo nasal ointment. 
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Jacob Monares — email: jmonares@ucdavis.edu

Urinary Tract Infections

Study Title: Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia coli Disease in Adults Aged 60 Years And Older with a History of Urinary Tract Infection in the Past 2 Years

  • Purpose: To demonstrate the efficacy and safety of ExPEC9V compared to placebo in the prevention of UTI.
  • Principal Investigator: Stuart Cohen, M.D.
  • Study Contact: Kenzie Usher — email: kcusher@ucdavis.edu