Digital Commons Network^™

Effectiveness Of Pfizer-Biontech Mrna Vaccination Against Covid-19 Hospitalization Among Persons Aged 12-18 Years - United States, June-September 2021., Samantha M. Olson, Margaret M. Newhams, Natasha B. Halasa, Ashley M. Price, Julie A. Boom, Leila C. Sahni, Katherine Irby, Tracie C. Walker, Stephanie P. Schwartz, Pia S. Pannaraj, Aline B. Maddux, Tamara T. Bradford, Ryan A. Nofziger, Benjamin J. Boutselis, Melissa L. Cullimore, Elizabeth H. Mack, Jennifer E. Schuster, Shira J. Gertz, Natalie Z. Cvijanovich, Michele Kong, Melissa A. Cameron, Mary A. Staat, Emily R. Levy, Brandon M. Chatani, Kathleen Chiotos, Laura D. Zambrano, Angela P. Campbell, Manish M. Patel, Adrienne G. Randolph, Overcoming Covid-19 Investigators

Manuscripts, Articles, Book Chapters and Other Papers

Pfizer-BioNTech COVID-19 vaccine is authorized for use in children and adolescents aged 12-15 years and is licensed by the Food and Drug Administration (FDA) for persons aged ≥16 (1). A randomized placebo-controlled trial demonstrated an efficacy of 100% (95% confidence interval [CI] = 75.3%-100%) in preventing outpatient COVID-19 in persons aged 12-15 years (2); however, data among adolescents on vaccine effectiveness (VE) against COVID-19 in real-world settings are limited, especially among hospitalized patients. In early September 2021, U.S. pediatric COVID-19 hospitalizations reached the highest level during the pandemic (3,4). In a test-negative, case-control study at 19 pediatric hospitals in 16 …

Effects Of The Tailored Activity Program (Tap) On Dementia-Related Symptoms, Health Events And Caregiver Wellbeing: A Randomized Controlled Trial, Laura N Gitlin, Katherine Marx, Catherine V. Piersol, Nancy A Hodgson, Jin Huang, David L Roth, Constantine Lyketsos

Department of Occupational Therapy Faculty Papers

BACKGROUND: People living with dementia (PLWD) and caregivers are adversely impacted by lack of meaningful activity leading to worse symptoms and impaired quality-of-life. There is a critical need to develop effective and well-tolerated treatments that mitigate clinical symptoms, engage PLWD and support caregiver wellbeing. We tested whether, compared to attention control, the Tailored Activity Program (TAP) reduced clinical symptoms and health-related events, and improved caregiver wellbeing, and if TAP activities were well-tolerated.

METHODS: We conducted a single-blind randomized controlled trial among 250 dyads recruited from Baltimore-Washington DC (2012-2016) with a dementia diagnosis and clinically significant agitation/aggression. Dyads were randomized to …

Health Of Asylees Compared To Refugees In The United States Using Domestic Medical Examination Data, 2014-2016: A Cross-Sectional Analysis., Gayathri S Kumar, Clelia Pezzi, Colleen Payton, Blain Mamo, Kailey Urban, Kevin Scott, Jessica Montour, Nuny Cabanting, Jenny Aguirre, Rebecca Ford, Stephen E Hughes, Breanna Kawasaki, Lori Kennedy, Emily S Jentes

College of Population Health Faculty Papers

Background: Between 2008 and 2018, persons granted asylum (asylees) increased by 168% in the United States. Asylees are eligible for many of the same domestic benefits as refugees under the US Refugee Admissions Program (USRAP), including health-related benefits such as the domestic medical examination. However, little is known about the health of asylees to guide clinical practice.

Methods: We conducted a retrospective cross-sectional analysis of domestic medical examination data from 9 US sites from 2014 to 2016. We describe and compare demographics and prevalence of several infectious diseases such as latent tuberculosis infection (LTBI), hepatitis B and C virus (HBV, …

Precision Food Parenting: A Proposed Conceptual Model And Research Agenda, Tom Baranowski, Debbe Thompson, Sheryl O Hughes, Teresia M O'Connor

Children’s Nutrition Research Center Staff Publications

Precision medicine, nutrition and behavioral interventions are attempting to move beyond the specification of therapies applied to groups, since some people benefit, some do not and some are harmed by the same therapy. Instead, precision therapies are attempting to employ diverse sets of data to individualize or tailor interventions to optimize the benefits for the receiving individuals. The benefits to be achieved are mostly in the distant future, but the research needs to start now. While precision pediatric nutrition will combine diverse demographic, behavioral and biological variables to specify the optimal foods a child should eat to optimize health, precision …

Elevated Mics Of Susceptible Antipseudomonal Cephalosporins In Non-Carbapenemase-Producing, Carbapenem-Resistant Pseudomonas Aeruginosa: Implications For Dose Optimization, Christian M Gill, Carey-Ann D Burnham, Et Al

Open Access Publications

The present study evaluated the

Trem2 Modulates Differential Deposition Of Modified And Non-Modified Aβ Species In Extracellular Plaques And Intraneuronal Deposits, Pranav Joshi, Florian Riffel, Sathish Kumar, Nàdia Villacampa, Sandra Theil, Samira Parhizkar, Christian Haass, Marco Colonna, Michael T Heneka, Thomas Arzberger, Jochen Herms, Jochen Walter

2020-Current year OA Pubs

Progressive accumulation of Amyloid-β (Aβ) deposits in the brain is a characteristic neuropathological hallmark of Alzheimer's disease (AD). During disease progression, extracellular Aβ plaques undergo specific changes in their composition by the sequential deposition of different modified Aβ species. Microglia are implicated in the restriction of amyloid deposits and play a major role in internalization and degradation of Aβ. Recent studies showed that rare variants of the Triggering Receptor Expressed on Myeloid cells 2 (TREM2) are associated with an increased risk for AD. Post-translational modifications of Aβ could modulate the interaction with TREM2, and the uptake by microglia. Here, we …

Computer-Assisted Analysis Of Oral Antifungal Therapy In Chronic Rhinosinusitis With Airway Mycosis: A Retrospective Cohort Analysis, Evan Li, Michael Scheurer, Farrah Kheradmand, Amber U Luong, David B Corry

Faculty, Staff and Student Publications

Environmental fungi are etiologically related to chronic rhinosinusitis (CRS) with airway mycosis, but their infectious role remains uncertain, in part because of potentially inadequate methods of disease quantitation. Our objective was to determine objective radiographic and symptomatic outcomes of oral antifungal therapy in adult patients with CRS and airway mycosis by using computer-assisted analysis. We conducted a retrospective study of 65 patients with CRS and culture-proven airway mycosis in a single-center referral-based academic practice, comparing paired sinus computed tomography (CT) scans and symptom scores prior to and during chronic oral antifungal therapy using computer-assisted analysis of sino-mucosal area (CAASMA). A …

Shape-Sensing Robotic-Assisted Bronchoscopy For Pulmonary Nodules: Initial Multicenter Experience Using The Ion™ Endoluminal System, Michael J. Simoff, Michael A. Pritchett, Janani S. Reisenauer, David E. Ost, Adnan Majid, Colleen Keyes, Roberto F. Casal, Mihir S. Parikh, Javier Diaz-Mendoza, Sebastian Fernandez-Bussy, Erik E. Folch

Pulmonary and Critical Care Medicine Articles

BACKGROUND: Traditional bronchoscopy provides limited approach to peripheral nodules. Shape-sensing robotic-assisted bronchoscopy (SSRAB, Ion™ Endoluminal System) is a new tool for minimally invasive peripheral nodule biopsy. We sought to answer the research question: Does SSRAB facilitate sampling of pulmonary nodules during bronchoscopists' initial experience?

METHODS: The lead-in stage of a multicenter, single-arm, prospective evaluation of the Ion Endoluminal System (PRECIsE) is described. Enrolled subjects ≥ 18 years old had recent computed tomography evidence of one or more solid or semi-solid pulmonary nodules ≥ 1.0 to ≤ 3.5 cm in greatest dimension and in any part of the lung. Subjects were …

Feasibility Evaluation Of Metamaterial Microwave Sensors For Non-Invasive Blood Glucose Monitoring, Lukas Malena, Ondrej Fiser, Paul R. Stauffer, Tomas Drizdal, Jan Vrba, David Vrba

Department of Radiation Oncology Faculty Papers

The use of microwave technology is currently under investigation for non-invasive estimation of glycemia in patients with diabetes. Due to their construction, metamaterial (MTM)-based sensors have the potential to provide higher sensitivity of the phase shift of the S21 parameter (∠S21 ) to changes in glucose concentration compared to standard microstrip transmission line (MSTL)-based sensors. In this study, a MSTL sensor and three MTM sensors with 5, 7, and 9 MTM unit cells are exposed to liquid phantoms with different dielectric properties mimicking a change in blood glucose concentration from 0 to 14 mmol/L. Numerical models were created for the …

Timing Of Antibiotic Therapy In The Icu, Marin H Kollef, Andrew F Shorr, Matteo Bassetti, Jean-Francois Timsit, Scott T Micek, Andrew P Michelson, Jose Garnacho-Montero

2020-Current year OA Pubs

Severe or life threatening infections are common among patients in the intensive care unit (ICU). Most infections in the ICU are bacterial or fungal in origin and require antimicrobial therapy for clinical resolution. Antibiotics are the cornerstone of therapy for infected critically ill patients. However, antibiotics are often not optimally administered resulting in less favorable patient outcomes including greater mortality. The timing of antibiotics in patients with life threatening infections including sepsis and septic shock is now recognized as one of the most important determinants of survival for this population. Individuals who have a delay in the administration of antibiotic …

Aducanumab For Alzheimer Disease: The Amyloid Hypothesis Moves From Bench To Bedside, Erik S. Musiek, Teresa Gomez-Isla, David M Holtzman

Open Access Publications

No abstract provided.

Feasibility And Effectiveness Of Recruiting Latinos In Decídetexto-A Smoking Cessation Clinical Trial From An Emergency Department Patient Registry, Evelyn Arana-Chicas, Francisco Cartujano-Barrera, Chinwe Ogedegbe, Edward F. Ellerbeck, Lisa Sanderson Cox, Kristi D. Graves, Francisco J. Diaz, Delwyn Catley, Ana Paula Cupertino

Manuscripts, Articles, Book Chapters and Other Papers

There is an underrepresentation of Latinos in smoking cessation clinical trials. This study describes the feasibility and effectiveness of recruiting Latino smokers in the U.S. from an emergency department (ED) patient registry into a randomized smoking cessation clinical trial. Recruitment occurred from the Hackensack University Medical Center ED. Potential participants were contacted from a patient registry. The primary outcome was whether the participant responded to a call or text. Secondary outcomes included the best day of the week, week of the month, and time of day to obtain a response. Of the 1680 potential participants, 1132 were called (67.5%), while …

Untargeted Metabolomic Analysis Of Human Milk From Mothers Of Preterm Infants, Lila S Nolan, Angela N Lewis, Qingqing Gong, James J Sollome, Olivia N Dewitt, Robert D Williams, Misty Good

2020-Current year OA Pubs

The application of metabolomics in neonatology offers an approach to investigate the complex relationship between nutrition and infant health. Characterization of the metabolome of human milk enables an investigation into nutrients that affect the neonatal metabolism and identification of dietary interventions for infants at risk of diseases such as necrotizing enterocolitis (NEC). In this study, we aimed to identify differences in the metabolome of breast milk of 48 mothers with preterm infants with NEC and non-NEC healthy controls. A minimum significant difference was observed in the human milk metabolome between the mothers of infants with NEC and mothers of healthy …

Norovirus Protease Structure And Antivirals Development, Boyang Zhao, Liya Hu, Yongcheng Song, Ketki Patil, Sasirekha Ramani, Robert L Atmar, Mary K Estes, B V Venkataram Prasad

Faculty, Staff and Students Publications

Human norovirus (HuNoV) infection is a global health and economic burden. Currently, there are no licensed HuNoV vaccines or antiviral drugs available. The protease encoded by the HuNoV genome plays a critical role in virus replication by cleaving the polyprotein and is an excellent target for developing small-molecule inhibitors. The current strategy for developing HuNoV protease inhibitors is by targeting the enzyme's active site and designing inhibitors that bind to the substrate-binding pockets located near the active site. However, subtle differential conformational flexibility in response to the different substrates in the polyprotein and structural differences in the active site and …

A Selective Antibiotic For Lyme Disease, Nadja Leimer, Xiaoqian Wu, Yu Imai, Madeleine Morrissette, Norman Pitt, Quentin Favre-Godal, Akira Iinishi, Samta Jain, Mariaelena Caboni, Inga V Leus, Vincent Bonifay, Samantha Niles, Rachel Bargabos, Meghan Ghiglieri, Rachel Corsetti, Megan Krumpoch, Gabriel Fox, Sangkeun Son, Dorota Klepacki, Yury S Polikanov, Cecily A Freliech, Julie E Mccarthy, Diane G Edmondson, Steven J Norris, Anthony D'Onofrio, Linden T Hu, Helen I Zgurskaya, Kim Lewis

Faculty, Staff and Student Publications

Lyme disease is on the rise. Caused by a spirochete Borreliella burgdorferi, it affects an estimated 500,000 people in the United States alone. The antibiotics currently used to treat Lyme disease are broad spectrum, damage the microbiome, and select for resistance in non-target bacteria. We therefore sought to identify a compound acting selectively against B. burgdorferi. A screen of soil micro-organisms revealed a compound highly selective against spirochetes, including B. burgdorferi. Unexpectedly, this compound was determined to be hygromycin A, a known antimicrobial produced by Streptomyces hygroscopicus. Hygromycin A targets the ribosomes and is taken up by B. burgdorferi, explaining …

Integrin Activation Is An Essential Component Of Sars-Cov-2 Infection, Peter Simons, Derek A. Rinaldi, Virginie Bondu, Alison M. Kell, Steven Bradfute, Diane S. Lidke, Tione Buranda

Pathology Research and Scholarship

SARS-CoV-2 infection depends on binding its spike (S) protein to angiotensin-converting enzyme 2 (ACE2). The S protein expresses an RGD motif, suggesting that integrins may be co-receptors. Here, we UV-inactivated SARS-CoV-2 and fluorescently labeled the envelope membrane with octadecyl rhodamine B (R18) to explore the role of integrin activation in mediating cell entry and productive infection. We used flow cytometry and confocal microscopy to show that SARS-CoV-2^R18 particles engage basal-state integrins. Furthermore, we demonstrate that Mn2+, which induces integrin extension, enhances cell entry of SARS-CoV-2^R18. We also show that one class of integrin antagonist, which binds to …

Tetraspanin Cd82 Regulates S1pr, Chelsea A. Saito-Reis, Victoria D. Balise, Erica M. Pascetti, Magdalena Jiminez, Jennifer M. Gillette

Pathology Research and Scholarship

Hematopoietic stem and progenitor cell (HSPC) mobilization into the blood occurs under normal physiological conditions and is stimulated in the clinic to enable the isolation of HSPCs for transplantation therapies. In the present study, we identify the tetraspanin CD82 as a novel regulator of HSPC mobilization. Using a global CD82 knockout (CD82KO) mouse, we measure enhanced HSPC mobilization after granulocyte-colony stimulating factor (G-CSF) or AMD3100 treatment, which we find is promoted by increased surface expression of the sphingosine 1-phosphate receptor 1 (S1PR

Long-Term Survival Of Older Patients Hospitalized For Covid-19. Do Clinical Characteristics Upon Admission Matter?, Michał Chojnicki, Agnieszka Neumann-Podczaska, Mikołaj Seostianin, Zofia Tomczak, Hamza Tariq, Jerzy Chudek, Sławomir Tobis, Iwona Mozer-Lisewska, Aleksandra Suwalska, Andrzej Tykarski, Piotr Merks, Sylwia Kropińska, Małgorzata Sobieszczańska, Frank Romanelli, Katarzyna Wieczorowska-Tobis

Pharmacy Practice and Science Faculty Publications

Older adults are particularly susceptible to COVID-19 in terms of both disease severity and risk of death. To compare clinical differences between older COVID-19 hospitalized survivors and non-survivors, we investigated variables influencing mortality in all older adults with COVID-19 hospitalized in Poznań, Poland, through the end of June 2020 (n = 322). In-hospital, post-discharge, and overall 180-day mortality were analyzed. Functional capacity prior to COVID-19 diagnosis was also documented. The mean age of subjects was 77.5 ± 10.0 years; among them, 191 were females. Ninety-five (29.5%) died during their hospitalization and an additional 30 (9.3%) during the post-discharge period …

Project Earthrise: Proceedings Of The Ninth Annual Conference Of Invivo Planetary Health, Susan L. Prescott, Ganesa Wegienka, Remco Kort, David H. Nelson, Sabine Gabrysch, Trevor Hancock, Anita Kozyrskyj, Christopher A. Lowry, Nicole Redvers, Blake Poland, Jake Robinson, Jean-Claude Moubarac, Sara Warber, Janet Jansson, Aki Sinkkonen, John Penders, Susan Erdman, Ralph Nanan, Matilda Van Den Bosch, Kirk Schneider, Nicholas J. Schroeck, Tanja Sobko, Jamie Harvie, George A. Kaplan, Rob Moodie, Laura Lengnick, Isaac Prilleltensky, Yuria Celidwen, Susan H. Berman, Alan C. Logan, Brian Berman

Public Health Sciences Articles

The "Earthrise" photograph, taken on the 1968 Apollo 8 mission, became one of the most significant images of the 20th Century. It triggered a profound shift in environmental awareness and the potential for human unity-inspiring the first Earth Day in 1970. Taking inspiration from these events 50 years later, we initiated

Cell-Based Therapies For Retinal Diseases: A Review Of Clinical Trials And Direct To Consumer "Cell Therapy" Clinics, John Hinkle, Raziyeh Mahmoudzadeh, Ajay E. Kuriyan

Wills Eye Hospital Papers

Background: The retinal pigment epithelium (RPE) is implicated in the pathophysiology of many retinal degenerative diseases. This cell layer is also an ideal target for cell-based therapies. Several early phase clinical trials evaluating cell therapy approaches for diseases involving the RPE, such as age-related macular degeneration and Stargardt's macular dystrophy have been published. However, there have also been numerous reports of complications from unproven "cell therapy" treatments marketed by "cell therapy" clinics. This review aims to outline the particular approaches in the different published clinical trials for cell-based therapies for retinal diseases. Additionally, the controversies surrounding experimental treatments offered outside …

Barriers To Symptom Management Care Pathway Implementation In Pediatric Cancer, L Lee Dupuis, Allison Grimes, Emily Vettese, Lisa M Klesges, Lillian Sung

2020-Current year OA Pubs

BACKGROUND: Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation.

METHODS: We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators prior to randomization to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of …

Derivation And External Validation Of A Simple Risk Score To Predict In-Hospital Mortality In Patients Hospitalized For Covid-19: A Multicenter Retrospective Cohort Study, Charlotte Z. Mann, Chelsea Abshire, Monica Yost, Scott Kaatz, Lakshmi Swaminathan, Scott A. Flanders, Hallie C. Prescott, Johann A. Gagnon-Bartsch

Hospital Medicine Articles

ABSTRACT: As severe acute respiratory syndrome coronavirus 2 continues to spread, easy-to-use risk models that predict hospital mortality can assist in clinical decision making and triage. We aimed to develop a risk score model for in-hospital mortality in patients hospitalized with 2019 novel coronavirus (COVID-19) that was robust across hospitals and used clinical factors that are readily available and measured standardly across hospitals. In this retrospective observational study, we developed a risk score model using data collected by trained abstractors for patients in 20 diverse hospitals across the state of Michigan (Mi-COVID19) who were discharged between March 5, 2020 and …

Prioritization Of Molecular Targets For Antimalarial Drug Discovery, Barbara Forte, Daniel E Goldberg, Eva S Istvan, Et Al

2020-Current year OA Pubs

There is a shift in antimalarial drug discovery from phenotypic screening toward target-based approaches, as more potential drug targets are being validated in

Inhibition Of The Nlrp3 Inflammasome Improves Lifespan In Animal Murine Model Of Hutchinson-Gilford Progeria, Alvaro González-Dominguez, Raúl Montañez, Beatriz Castejón-Vega, Jéssica Nuñez-Vasco, Débora Lendines-Cordero, Chun Wang, Gabriel Mbalaviele, José M Navarro-Pando, Elísabet Alcocer-Gómez, Mario D Cordero

Open Access Publications

Inflammation is a hallmark of aging and accelerated aging syndromes such as Hutchinson-Gilford progeria syndrome (HGPS). In this study, we present evidence of increased expression of the components of the NLRP3 inflammasome pathway in HGPS skin fibroblasts, an outcome that was associated with morphological changes of the nuclei of the cells. Lymphoblasts from HGPS patients also showed increased basal levels of NLRP3 and caspase 1. Consistent with these results, the expression of caspase 1 and Nlrp3, but not of the other inflammasome receptors was higher in the heart and liver of Zmpste24

The Individual Water Insecurity Experiences (Iwise) Scale: Reliability, Equivalence And Validity Of An Individual-Level Measure Of Water Security, Sera L. Young, Hilary J. Bethancourt, Zacchary R. Ritter, Edward A. Frongillo Jr.

Faculty Publications

Objective: The lack of a validated and cross-culturally equivalent scale for measuring individual-level water insecurity has prevented identification of those most vulnerable to it. Therefore, we developed the 12-item Individual Water InSecurity Experiences (IWISE) Scale to comparably measure individual experiences with access, use, and stability (reliability) of water. Here, we examine the reliability, cross-country equivalence, and cross-country and within-country validity of the scale in a cross-sectional sample.

Methods: IWISE items were implemented by the Gallup World Poll among nationally representative samples of 43 970 adults (15 y) in 31 low-income and middle-income countries (LMICs). Internal consistency was assessed …

Single-Cell Epigenomics Reveals Mechanisms Of Human Cortical Development, Ryan S Ziffra, Tychele N Turner, Et Al.

2020-Current year OA Pubs

During mammalian development, differences in chromatin state coincide with cellular differentiation and reflect changes in the gene regulatory landscape

Disparities In Treatment Decisions For Abnormal Uterine Bleeding, Lulu Yu, Bhavana Janga, Rebecca Mcalister, Donna B Jeffe, Tammy Sonn

Open Access Publications

No abstract provided.

Patient-Reported Reasons For Stopping Care Or Switching Clinics In Zambia: A Multisite, Regionally Representative Estimate Using A Multistage Sampling-Based Approach In Zambia, Izukanji Sikazwe, Ingrid Eshun-Wilson, Kombatende Sikombe, Laura K Beres, Paul Somwe, Aaloke Mody, Sandra Simbeza, Chama Bukankala, David V Glidden, Lloyd B Mulenga, Nancy Padian, Peter Ehrenkranz, Carolyn Bolton-Moore, Charles B Holmes, Elvin H Geng

2020-Current year OA Pubs

BACKGROUND: Understanding patient-reported reasons for lapses of retention in human immunodeficiency virus (HIV) treatment can drive improvements in the care cascade. A systematic assessment of outcomes among a random sample of patients lost to follow-up (LTFU) from 32 clinics in Zambia to understand the reasons for silent transfers and disengagement from care was undertaken.

METHODS: We traced a simple random sample of LTFU patients (>90 days from last scheduled visit) as determined from clinic-based electronic medical records from a probability sample of facilities. Among patients found in person, we solicited reasons for either stopping or switching care and predictors …

Neuron-Specific Imp2 Overexpression By Synapsin Promoter-Driven Aav9: A Tool To Study Its Role In Axon Regeneration., Sarah Blizard, Danielle Park, Natalie O'Toole, Sheeva Norooz, Martin Dela Torre, Young Son, Adam Holstein, Scarlett Austin, Joshua Harman, Samantha Haraszti, Daved Fared, Mei Xu

PCOM Scholarly Works

Insulin-like growth factor II mRNA-binding protein (IMP) 2 is one of the three homologues (IMP1-3) that belong to a conserved family of mRNA-binding proteins. Its alternative splice product is aberrantly expressed in human hepatocellular carcinoma, and it is therefore identified as HCC. Previous works have indicated that IMP1/ZBP1 (zipcode binding protein) is critical in axon guidance and regeneration by regulating localization and translation of specific mRNAs. However, the role of IMP2 in the nervous system is largely unknown. We used the synapsin promoter-driven adeno-associated viral (AAV) 9 constructs for transgene expression both in vitro and in vivo. These viral vectors …

A Randomized Phase 2 Study Of Vt-1161 For The Treatment Of Acute Vulvovaginal Candidiasis, Stephen R Brand, Jack D Sobel, Paul Nyirjesy, Mahmoud A Ghannoum, Robert J Schotzinger, Thorsten P Degenhardt

Department of Obstetrics and Gynecology Faculty Papers

Background: Acute vulvovaginal candidiasis (VVC) is common among women, but current azole antifungal treatments are often associated with safety and resistance issues. VT-1161 (oteseconazole) is an oral agent with increased selectivity for fungal CYP51. In this phase 2 clinical study, we evaluated the efficacy and safety of VT-1161 vs fluconazole in participants with moderate to severe acute VVC.

Methods: Participants presenting with an acute episode of VVC (n = 55) were randomized to receive VT-1161 300 mg once daily (q.d.) for 3 days, 600 mg q.d. for 3 days, or 600 mg twice daily (b.i.d.) for 3 days or to …