Robert Orenstein, D.O.

Closed for Enrollment

• A Double-Blind Placebo-Controlled Phase 2 Study of VE303 for Prevention of Recurrent Clostridium (Clostridioides) Difficile Infection (CONSORTIUM) Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate the safety and effectiveness of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).

• A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota® (CP101) in Subjects with Recurrence of Clostridium difficile Infection (PRISM3) Scottsdale/Phoenix, Ariz.

  This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota® (CP101) in Subjects with Recurrence of Clostridium difficile Infection (PRISM3)

• A Non-Interventional Registry Study of Systemic Antifungal Therapy in Adult Subjects with Invasive Mucormycosis or Invasive Aspergillosis Caused by a Non-fumigatus Species (9766-CL-0111) Scottsdale/Phoenix, Ariz.

  The purpose of this study is to obtain and report outcome data for adult subjects who received systemic antifungal therapy (AFT) for the treatment of invasive mucormycosis (IM) or invasive aspergillosis (IA) caused by a non-fumigatus species.

• A Phase 2 Open-label Clinical Trial Demonstrating the Safety of RBX2660 Microbiota Suspension for the Treatment of Recurrent Clostridium Difficile-associated Diarrhea (CDAD): the PUNCH CD Study 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.

• A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection Scottsdale/Phoenix, Ariz.

  The purpose of this study is to confirm the effectiveness of RBX2660 as compared to a placebo in preventing recurrent episodes of Clostridium difficile Infection (CDI) through 8 weeks.

   

   

   

• A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia (HGEN003-06) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz. The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care (SOC) can alleviate the immune-mediated cytokine release syndrome (CRS) and prevent progression to respiratory failure and/or death in high risk patients with COVID-19 pneumonia.
• A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection (THE RESTORATIVE303 STUDY) Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).

  Only adults will be enrolled at Mayo Clinic Arizona

• An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection Scottsdale/Phoenix, Ariz.

  This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI). Enrolled subjects will receive one treatment with RBX2660 (microbiota suspension).

• Donor Screening Experience and Outcomes from Fecal Transplant in Patients with C. Difficile Infection Scottsdale/Phoenix, Ariz., Rochester, Minn.

  The purpose of this study is to evaluate clinical experience with donor screening for fecal transplant, and to evaluate the outcomes from fecal transplant and understand risk factors for fecal transplant failure and relapse after fecal transplant.

• Metagenomic Next-Generation Sequencing (mNGS): Use at Mayo Clinic for a Difficult Case of Meningoencephalitis Scottsdale/Phoenix, Ariz.

  The purpose of this study is to identify known and unknown pathogens and antibodies that can cause severe disease in hospitalized patients.

• PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection (PRISM-EXT) Scottsdale/Phoenix, Ariz.

  The purpose of this open-label extension of CDI-001 (subsequently referred to as PRISM 3) is to evaluate the safety and efficacy in reducing recurrence of CDI in adults who had a recurrence within 8 weeks of receiving CP101 or placebo in PRISM 3. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in the extension study and administered CP101. Approximately 70 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.

• VC-02-01, A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination with Intravenous Remdesivir in Adult Patients with Advanced Coronavirus Disease 2019 (COVID-19) (VC-02-01) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  This study will evaluate the efficacy of merimepodib (MMPD) administered orally every eight hours (q8h) for 10 days in adult patients with advanced COVID-19.