Safety and Tolerability of CP101, a Full-Spectrum, Oral Microbiome Therapeutic for the Prevention of Recurrent Clostridioides difficile Infection: A Phase 2 Randomized Controlled Trial

Authors: Allegretti, Jessica R. ^{1, ∗}, Kelly, Colleen R. ², Louie, Thomas ³, Fischer, Monika ⁴, Hota, Susy ⁵, Misra, Bharat ⁶, Van Hise, Nick W. ⁷, Yen, Eugene ⁸, Bullock, Jeffrey S. ⁹, Silverman, Michael ¹⁰, Davis, Ian ¹¹, McGill, Sarah K. ¹², Pardi, Darrell S. ¹³, Orenstein, Robert ¹⁴, Grinspan, Ari ¹⁵, El-Nachef, Najwa ¹⁶, Feuerstadt, Paul ¹⁷, Borody, Thomas J. ¹⁸, Khanna, Sahil ¹³, Budree, Shrish ^{19, §}, Kassam, Zain ^{20, §}

Source: In Gastroenterology February 2025 168(2):357-366

Association of Neutralizing Antispike Monoclonal Antibody Treatment With Coronavirus Disease 2019 Hospitalization and Assessment of the Monoclonal Antibody Screening Score

Authors: Johnson, Patrick W., Kunze, Katie L., Senefeld, Jonathon W., Sinclair, Jorge E., Isha, Shahin, Satashia, Parthkumar H., Bhakta, Shivang, Cowart, Jennifer B., Bosch, Wendelyn, O’Horo, Jack, Shah, Sadia Z., Wadei, Hani M., Edwards, Michael A., Pollock, Benjamin D., Edwards, Alana J., Scheitel-Tulledge, Sidna, Clune, Caroline G., Hanson, Sara N., Arndt, Richard, Heyliger, Alexander, Kudrna, Cory, Bierle, Dennis M., Buckmeier, Jason R., Seville, Maria Teresa A., Orenstein, Robert, Libertin, Claudia, Ganesh, Ravindra, Franco, Pablo Moreno, Razonable, Raymund R., Carter, Rickey E., Sanghavi, Devang K., Speicher, Leigh L.

Source: In Mayo Clinic Proceedings: Innovations, Quality & Outcomes April 2023 7(2):109-121

Impact of a High-Risk, Ambulatory COVID-19 Remote Patient Monitoring Program on Utilization, Cost, and Mortality

Authors: Haddad, Tufia C., Coffey, Jordan D., Deng, Yihong, Glasgow, Amy E., Christopherson, Laura A., Sangaralingham, Lindsey R., Bell, Sarah J., Shah, Vishal P., Pritchett, Joshua C., Orenstein, Robert, Speicher, Leigh L., Maniaci, Michael J., Ganesh, Ravindra, Borah, Bijan J.

Source: In Mayo Clinic Proceedings December 2022 97(12):2215-2225

Clinical Characteristics and Outcomes of Patients With SARS-CoV-2 Reinfection

Authors: Comba, Isin Yagmur, Riestra Guiance, Irene, Corsini Campioli, Cristina, Challener, Douglas, Sampathkumar, Priya, Orenstein, Robert, Gordon, Joel, Bosch, Wendelyn, O’Horo, John C.

Source: In Mayo Clinic Proceedings: Innovations, Quality & Outcomes August 2022 6(4):361-372

Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial

Authors: Lewis, Meghan, Sher, Linda, Bowdish, Michael, Wald-Dickler, Noah, Biswas, Subarna, Lam, Lydia, Vo, Khang, Poblete, Roy, Lee, May M., Hutcheon, Douglass, Patron, Roberto, Gharbin, John, Moran, Caitlin, Kandiah, Sheetal, Cantos, Valeria, Rebolledo, Paulina, del Rio, Carlos, Lennox, Jeffrey, Polito, Carmen, Sheth, Anandi, Patel, Anup, Paniagua, Homero, Yohannes, Seife, Amin, Alpesh, Lee, Richard, Watanabe, Miki, Hsieh, Lanny, Cearras, Martin, Parikh, Amay, Sniffen, Jason, Onyia, Wilfred, Boger, Michael, Davidson, Lisa, Gajurel, Kiran, Leonard, Michael, McCurdy, Lewis, Quezada, Nestor, Sampson, Mindy, Shahid, Zainab, Strollo, Stephanie, Weinrib, David, Zulfigar, Sara, McDonald, Cheryl, Hollingsworth, John, Burk, John, Berg, Joshua, Barbaro, Daniel, Miller, Andrew, Sambathkumar, Lakshmi, McDonald, Stuart, Okoye, Obinna, Pulido, Juan, Fulton, Jennifer, Gill, William, Zuckerman, Richard, Lewis, Lionel, Mandapakala, Chaitanya, Robinson, Matthew, Metzger, Brian, Alam, Maqsood, Politis, Chrisoula, Frosch, Anne, Ngo, Linh, Carvalho Neuenschwander, Fernando, Figueiredo, EstevÃo, CanÇado, Gualter, Araujo, Gustavo, GuimarÃes, Lucas, Diaz, Ricardo, Bacellar, Natalia, Silva, Celso, Ferreira, Paulo, Andrade Lima, Marina, Uber Ghisi, Caroline, Anton, Camila, Albaneze, Ricardo, Wagner de Castro Lima Santos, Daniel, Iglessias, Ana Caroline, Lago, Marianna, Pietrobom, Paula, Alves, Maysa, Duailibe Furtado, Juvencio José, Trevelin, Leopoldo, Telles, Valeria, Correa, Francini, Ramos, Fabiano, de A. R. Da Silva, Marina, Lacerda Garcia, Rebeca C., Maldonado, Ana Elizabeth G., Beheregaray, Ana Carolina M., Ortiz, Ana Maria T., Luz, Kleber, Pipolo Milan, Eveline, Soares de Castro, Janine, Barbosa Moreira, Matheus José, Bezerra Onofre, Renata, do Nascimento JÁcome, TÁcito, Barreto Garcia, Victor, Rolim de Souzafrom, Victor Matheus, Dal Pizzol, Felipe, Ritter, Cristiane, Vinhas, Marcelo B., Westheimer Cavalcante, Adilson Joaquim, Minghini, Julia, Dorigo, Loni, Salgado Miranda, Marina, Antila, Martti Anton, Brugnolli, Rebeca, Antila, Henrikki, Temesgen, Zelalem ^*, Burger, Charles D, Baker, Jason, Polk, Christopher, Libertin, Claudia R, Kelley, Colleen F, Marconi, Vincent C, Orenstein, Robert, Catterson, Victoria M, Aronstein, William S, Durrant, Cameron, Chappell, Dale, Ahmed, Omar, Chappell, Gabrielle, Badley, Andrew D

Source: In The Lancet Respiratory Medicine March 2022 10(3):237-246

A Framework for Outpatient Infusion of Antispike Monoclonal Antibodies to High-Risk Patients with Mild-to-Moderate Coronavirus Disease-19: The Mayo Clinic Model

Authors: Razonable, Raymund R., Aloia, Nicole C.E., Anderson, Ryan J., Anil, Gokhan, Arndt, Lori L., Arndt, Richard F., Ausman, Sara E., Bell, Sarah J., Bierle, Dennis M., Billings, Marcie L., Bishop, Rachel K., Cramer, Carl H., Culbertson, Tracy L., Dababneh, Ala S., Derr, Amber N., Epps, Kevin, Flaker, Susan M., Ganesh, Ravindra, Gilmer, Mary A., Urena, Eric Gomez, Gulden, Christopher R., Haack, Tamara L., Hanson, Sara N., Herzog, Jenna R., Heyliger, Alexander, Hokanson, Lex D., Hopkins, Laura H., Horecki, Richard J., Krishna, Bipinchandra Hirisave, Huskins, W. Charles, Jackson, Tammy A., Johnson, Ryan R., Jorgenson, Betty, Kudrna, Cory, Kennedy, Brian D., Klingsporn, Mary K., Kottke, Brian, Larsen, Jennifer J., Lessard, Sarah R., Lutwick, Larry I., Malone, Edward J., III, Matoush, Jennifer A., Micallef, Ivana N., Moehnke, Darcie E., Mohamed, Muhanad, Ness, Colleena N., Olson, Shelly M., Orenstein, Robert, Palraj, Raj, Patel, Janki, Paulson, Damian J., Phelan, David, Peinovich, Margaret T., Ramsey, Wilford L., Rau-Kane, Taunya J., Reid, Kevin I., Reinschmidt, Karen J., Seville, Maria Teresa, Skold, Erin C., Smith, Jill M., Speicher, Leigh L., Spielman, Laurie A., Springer, Donna J., Sweeten, Perry W., Tempelis, Jennifer M., Tulledge-Scheitel, Sidna, Vergidis, Paschalis, Whipple, Daniel C., Wilker, Caroline G., Destro Borgen, Molly J.

Source: In Mayo Clinic Proceedings May 2021 96(5):1250-1261

Outcomes of COVID-19 With the Mayo Clinic Model of Care and Research

Authors: O’Horo, John Charles, Cerhan, James R., Cahn, Elliot J., Bauer, Philippe R., Temesgen, Zelalem, Ebbert, Jon, Abril, Andy, Abu Saleh, Omar M., Assi, Mariam, Berbari, Elie F., Bierle, Dennis M., Bosch, Wendelyn, Burger, Charles D., Cano Cevallos, Edison J., Clements, Casey M., Carmona Porquera, Eva M., Castillo Almeida, Natalia E., Challener, Douglas W., Chesdachai, Supavit, Comba, Isin Y., Corsini Campioli, Cristina G., Crane, Sarah J., Dababneh, Ala S., Enzler, Mark J., Fadel, Hind J., Ganesh, Ravindra, De Moraes, Alice Gallo, Go, John R., Gordon, Joel E., Gurram, Pooja R., Guru, Pramod K., Halverson, Erika L., Harrison, Michael F., Heaton, Heather A., Hurt, Ryan, Kasten, Mary J., Lee, Augustine S., Levy, Emily R., Libertin, Claudia R., Mallea, Jorge M., Marshall, William F., III, Matcha, Gautam, Meehan, Anne M., Franco, Pablo Moreno, Morice, William G., II, O’Brien, Jennifer J., Oeckler, Richard, Ommen, Steve, Oravec, Caitlin P., Orenstein, Robert, Ough, Natalie J., Palraj, Raj, Patel, Bhavesh M., Pureza, Vincent S., Pickering, Brian, Phelan, David M., Razonable, Raymund R., Rizza, Stacey, Sampathkumar, Priya, Sanghavi, Devang K., Sen, Ayan, Siegel, Jason L., Singbartl, Kai, Shah, Aditya S., Shweta, FNU, Speicher, Leigh L., Suh, Gina, Tabaja, Hussam, Jr., Tande, Aaron, Ting, Henry H., Tontz, Russell C., III, Vaillant, James J., Vergidis, Paschalis, Warsame, Mohamed Y., Yetmar, Zachary A., Zomok, Catherine (Cate) D., Williams, Amy W., Badley, Andrew D.

Source: In Mayo Clinic Proceedings March 2021 96(3):601-618

Neisseria sicca Vertebral Osteomyelitis: A Case Report and Literature Review.

Authors: Dyal, Natasha Priya¹ (AUTHOR) dyal.natasha@mayo.edu, Orenstein, Robert¹ (AUTHOR), Nagarakanti, Sandhya Rani¹ (AUTHOR) nagarakanti.sandhya@mayo.edu

Source: Journal of Clinical Medicine. Dec2024, Vol. 13 Issue 23, p7241. 10p.

Subject Terms: *TYPE 2 diabetes, *MICROBIAL cultures, *SPINAL fusion, *ATRIAL fibrillation, *BACKACHE

GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia: A Case-Cohort Study

Authors: Temesgen, Zelalem, Assi, Mariam, Shweta, F.N.U., Vergidis, Paschalis, Rizza, Stacey A., Bauer, Philippe R., Pickering, Brian W., Razonable, Raymund R., Libertin, Claudia R., Burger, Charles D., Orenstein, Robert, Vargas, Hugo E., Palraj, Raj, Dababneh, Ala S., Chappell, Gabrielle, Chappell, Dale, Ahmed, Omar, Sakemura, Reona, Durrant, Cameron, Kenderian, Saad S., Badley, Andrew D.

Source: In Mayo Clinic Proceedings November 2020 95(11):2382-2394

Research Response to SARS-CoV-2/COVID-19

Authors: Burger, Charles D., Mikhail, Amanda E., Orenstein, Robert, Ebbert, Jon O., Vergidis, Paschalis, Badley, Andrew D.

Source: In Mayo Clinic Proceedings September 2020 95(9) Supplement:S52-S55

Results From a Randomized, Placebo-Controlled Clinical Trial of a RBX2660—A Microbiota-Based Drug for the Prevention of Recurrent Clostridium difficile Infection

Authors: Dubberke, Erik R., Lee, Christine H., Orenstein, Robert, Khanna, Sahil, Hecht, Gail, Gerding, Dale N.

Source: Clinical Infectious Diseases, 2018 Oct . 67(8), 1198-1204.

Access URL: https://www.jstor.org/stable/26526821

Final Results from a Phase 2b Randomized, Placebo-Controlled Clinical Trial of RBX2660: A Microbiota-Based Drug for the Prevention of Recurrent Clostridioides difficile Infection.

Authors: Dubberke, Erik R.^1,2 (AUTHOR) edubberk@wustl.edu, Orenstein, Robert³ (AUTHOR), Khanna, Sahil⁴ (AUTHOR), Guthmueller, Beth⁵ (AUTHOR), Lee, Christine⁶ (AUTHOR)

Source: Infectious Diseases & Therapy. Feb2023, Vol. 12 Issue 2, p703-709. 7p.

Subject Terms: *CLOSTRIDIOIDES difficile, *CLINICAL trials, *TREATMENT effectiveness

The Role of Microbiome-Based Therapeutics in Clostridioides difficile Infection: Durable, Long-Term Results of RBX2660.

Authors: Orenstein, Robert¹ (AUTHOR) orenstein.robert@mayo.edu

Source: Infectious Diseases & Therapy. Jan2023, Vol. 12 Issue 1, p1-7. 7p.

Subject Terms: *CLOSTRIDIOIDES difficile, *INFLAMMATORY bowel diseases, *RECTAL administration, *THERAPEUTICS, *GUT microbiome

Company/Entity: UNITED States. Food & Drug Administration

Low Risk of Primary Clostridium difficile Infection With Tetracyclines : A Systematic Review and Metaanalysis

Authors: Tariq, Raseen, Cho, Janice, Kapoor, Saloni, Orenstein, Robert, Singh, Siddharth, Pardi, Darrell S., Khanna, Sahil

Source: Clinical Infectious Diseases, 2018 Feb . 66(4), 514-522.

Access URL: https://www.jstor.org/stable/26573610

Mini-Fecal Microbiota Transplantation for Treatment of Clostridium difficile Proctitis Following Total Colectomy

Authors: Orenstein, Robert, King, Kara, Patron, Roberto L., DiBaise, John K., Etzioni, David

Source: Clinical Infectious Diseases, 2018 Jan . 66(2), 299-300.

Access URL: https://www.jstor.org/stable/26525934

Vancomycin Taper and Risk of Failure of Fecal Microbiota Transplantation in Patients With Recurrent Clostridium difficile Infection

Authors: Patron, Roberto L., Hartmann, Carlos A., Allen, Sorcha, Griesbach, Cheryl L., Kosiorek, Heidi E., Dibaise, John K., Orenstein, Robert

Source: Clinical Infectious Diseases, 2017 Oct 01. 65(7), 1214-1217.

Access URL: https://www.jstor.org/stable/26375726

Deep Sternal Wound Infection Caused by Rhizopus Species After Coronary Artery Bypass Graft.

Authors: Cunningham, Cody A, Grys, Thomas E, Downey, Francis X, Saling, Christopher F, Orenstein, Robert, Blair, Janis E

Source: Open Forum Infectious Diseases; Jun2024, Vol. 11 Issue 6, p1-4, 4p

Subject Terms: WOUND infections, CORONARY artery bypass, MEDIASTINITIS, RHIZOPUS, HOSPITAL admission & discharge, CARDIAC surgery, AMPHOTERICIN B

Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial.

Authors: Orenstein, Robert¹ (AUTHOR) Orenstein.Robert@mayo.edu, Dubberke, Erik R.² (AUTHOR), Khanna, Sahil³ (AUTHOR), Lee, Christine H.^4,5,6 (AUTHOR), Yoho, David⁷ (AUTHOR), Johnson, Stuart^8,9 (AUTHOR), Hecht, Gail¹⁰ (AUTHOR), DuPont, Herbert L.¹¹ (AUTHOR), Gerding, Dale N.⁹ (AUTHOR), Blount, Ken F.¹² (AUTHOR), Mische, Sarah¹² (AUTHOR), Harvey, Adam¹² (AUTHOR)

Source: BMC Infectious Diseases. 3/12/2022, Vol. 22 Issue 1, p1-13. 13p.

Subject Terms: *FECAL microbiota transplantation, *CLOSTRIDIOIDES difficile, *DISEASE relapse, *CLINICAL trial registries, *CLINICAL trials

Safety and Durability of RBX2660 (Microbiota Suspension) for Recurrent Clostridium difficile Infection: Results of the PUNCH CD Study

Authors: PUNCH CD Investigators, Orenstein, Robert, Dubberke, Erik, Hardi, Robert, Ray, Arnab, Mullane, Kathleen, Pardi, Darrell S., Ramesh, Mayur S.

Source: Clinical Infectious Diseases, 2016 Mar 01. 62(5), 596-602.

Access URL: https://www.jstor.org/stable/26370303

Coccidioidal Tenosynovitis of the Hand and Wrist: Report of 9 Cases and Review of the Literature

Authors: Campbell, Mark, Kusne, Shimon, Renfree, Kevin J., Vikram, Holenarasipur R., Smilack, Jerry D., Seville, Maria T., Orenstein, Robert, Blair, Janis E.

Source: Clinical Infectious Diseases, 2015 Nov . 61(10), 1514-1520.

Access URL: https://www.jstor.org/stable/26369202