Anne J Gonzales-Luna
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View article: 435. Evaluation of Fecal Pharmacokinetics and Metagenomic Changes Following the Administration of Intravenous Omadacycline to Healthy Subjects
435. Evaluation of Fecal Pharmacokinetics and Metagenomic Changes Following the Administration of Intravenous Omadacycline to Healthy Subjects Open
Background Omadacycline (OMC), an aminomethylcycline antibiotic, has potent in vitro activity against C. difficile (CD) and has been associated with a low propensity to cause CD infection when used to treat other infections. A recent phase…
View article: P-200. Preliminary Results from a Multistate <i>C. difficile</i> Surveillance Network: The Surveillance Highlighting Existing/Emerging Resistance Limiting Our <i>C. difficile</i> Knowledge (SHERLOCK) Project
P-200. Preliminary Results from a Multistate <i>C. difficile</i> Surveillance Network: The Surveillance Highlighting Existing/Emerging Resistance Limiting Our <i>C. difficile</i> Knowledge (SHERLOCK) Project Open
Background C. difficile infection is unique in that the diagnosis is made via the identification of toxins in stool rather than by bacterial growth. Therefore, strain typing and antibiotic susceptibility testing are not routinely performed…
View article: P-221. Ribotype Ecology and 90-day Mortality Changes after a CDI Diagnostic Change from a PCR-based to a 2-step Diagnostic Algorithm
P-221. Ribotype Ecology and 90-day Mortality Changes after a CDI Diagnostic Change from a PCR-based to a 2-step Diagnostic Algorithm Open
Background Due to detection of Clostridioides difficile colonization, many hospitals changed from a PCR-based CDI diagnostic to a two-step diagnostic using a GDH/EIA assay. How this change affected the ecology of diagnostic C. difficile st…
View article: Defining Fulminant <i>Clostridioides difficile</i> Infections: Assessing the Utility of Hypotension as a Diagnostic Criterion
Defining Fulminant <i>Clostridioides difficile</i> Infections: Assessing the Utility of Hypotension as a Diagnostic Criterion Open
Background Fulminant Clostridioides difficile infection (FCDI) is associated with a 30%–40% mortality rate. Guideline definitions for FCDI severity classification include ileus, megacolon, shock, or hypotension. However, no hypotension def…
View article: Reduced Vancomycin Susceptibility in <i>Clostridioides difficile</i> Is Associated With Specific Ribotypes
Reduced Vancomycin Susceptibility in <i>Clostridioides difficile</i> Is Associated With Specific Ribotypes Open
Background Reduced vancomycin (VAN) susceptibility in clinical Clostridioides difficile isolates is correlated with poor clinical outcomes. However, factors associated with infection with these strains are unknown. The goal of this study w…
View article: Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), Among Patients Exposed to Non–<i>Clostridioides difficile</i> Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Study
Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), Among Patients Exposed to Non–<i>Clostridioides difficile</i> Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Study Open
Background Antibiotic use is a major risk factor for recurrent Clostridioides difficile infection (CDI) due to the associated disruption in gut microbiota. Fecal microbiota, live-jslm (REBYOTA®; RBL, previously RBX2660), is the first micro…
View article: Reduced Vancomycin Susceptibility in <i>Clostridioides difficile</i> Is Associated With Lower Rates of Initial Cure and Sustained Clinical Response
Reduced Vancomycin Susceptibility in <i>Clostridioides difficile</i> Is Associated With Lower Rates of Initial Cure and Sustained Clinical Response Open
Background Epidemiologic studies have shown decreasing vancomycin susceptibility among clinical Clostridioides difficile isolates, but the impact on patient outcomes is unknown. We hypothesized that reduced vancomycin susceptibility would …
View article: Antibacterial activity of ibezapolstat against antimicrobial-resistant clinical strains of <i>Clostridioides difficile</i>
Antibacterial activity of ibezapolstat against antimicrobial-resistant clinical strains of <i>Clostridioides difficile</i> Open
Antimicrobial resistance is emerging in clinical strains of Clostridioides difficile . Ibezapolstat (IBZ) is a DNA polymerase IIIC inhibitor that has completed phase II clinical trials. IBZ has potent in vitro activity against wild-type, s…
View article: Informing estimates of probability of <i>Clostridioides difficile</i> infection for testing and treatment: expert consensus from a modified-Delphi procedure
Informing estimates of probability of <i>Clostridioides difficile</i> infection for testing and treatment: expert consensus from a modified-Delphi procedure Open
Background: Clostridioides difficile infection (CDI) may be misdiagnosed if testing is performed in the absence of signs or symptoms of disease. This study sought to support appropriate testing by estimating the impact of signs, symptoms, …
View article: Systematic review of the orally administered microbiome therapeutic, fecal microbiota spores, live-brpk, to prevent recurrence of <i>Clostridioides difficile</i> infection in adults
Systematic review of the orally administered microbiome therapeutic, fecal microbiota spores, live-brpk, to prevent recurrence of <i>Clostridioides difficile</i> infection in adults Open
Background: Clostridioides difficile infection (CDI) has been linked to over 200,000 cases of illness in hospitalized patients and over 20,000 deaths annually. Up to 25% of patients with an initial CDI episode will experience recurrent CDI…
View article: Fecal Pharmacokinetics and Gut Microbiome Effects of Oral Omadacycline Versus Vancomycin in Healthy Volunteers
Fecal Pharmacokinetics and Gut Microbiome Effects of Oral Omadacycline Versus Vancomycin in Healthy Volunteers Open
Background Clostridioides difficile infection (CDI) is a common healthcare-associated infection with limited treatment options. Omadacycline, an aminomethylcycline tetracycline, has potent in vitro activity against C difficile and a low pr…
View article: Review Article: Safety of Live Biotherapeutic Products Used for the Prevention of <i>Clostridioides difficile</i> Infection Recurrence
Review Article: Safety of Live Biotherapeutic Products Used for the Prevention of <i>Clostridioides difficile</i> Infection Recurrence Open
Live biotherapeutic products (LBPs) represent a new class of therapeutics indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in adults. However, microbiota-based therapies have been used in CDI management befor…
View article: 682. Novel <i>rpoB</i> mutations and trends in clinical <i>Clostridioides difficile</i> isolates with reduced fidaxomicin susceptibility
682. Novel <i>rpoB</i> mutations and trends in clinical <i>Clostridioides difficile</i> isolates with reduced fidaxomicin susceptibility Open
Background Fidaxomicin use is increasing to treat Clostridioides difficile infection (CDI) following clinical treatment guideline updates placing it as first-line therapy. This puts a selection pressure on the development of fidaxomicin re…
View article: 277. A Functional OMICs Evaluation of Omadacycline to Understand Anti-<i>Clostridioides difficile</i> Protective Effects
277. A Functional OMICs Evaluation of Omadacycline to Understand Anti-<i>Clostridioides difficile</i> Protective Effects Open
Background Omadacycline is an aminomethylcycline tetracycline with potent in vitro activity against C. difficile (CD) and a low propensity for CD infection (CDI) in clinical trials. In addition to potent in vitro activity, ideal properties…
View article: 653. Rapid Change in Microbiome Profiles Regardless of Diagnostic Method in a Post Hoc Comparative Analysis of Phase 3 Trials of Fecal Microbiota Spores, Live-brpk (formerly SER-109) for the Prevention of Recurrent <i>Clostridioides difficile</i> Infection (rCDI)
653. Rapid Change in Microbiome Profiles Regardless of Diagnostic Method in a Post Hoc Comparative Analysis of Phase 3 Trials of Fecal Microbiota Spores, Live-brpk (formerly SER-109) for the Prevention of Recurrent <i>Clostridioides difficile</i> Infection (rCDI) Open
Background rCDI is characterized by diarrhea reemergence after symptom resolution on standard-of-care antibiotics and positive test for C. difficile toxin production or toxin gene presence. In two phase 3 trials with varied diagnostic test…
View article: 674. Host and Pathogen Risk Factors for Fulminant <i>Clostridioides difficile</i> Infection
674. Host and Pathogen Risk Factors for Fulminant <i>Clostridioides difficile</i> Infection Open
Background Fulminant Clostridioides difficile infection (FCDI) is associated with high rates of mortality and morbidity; however, risk factors for FCDI are poorly understood. The objective of this study was to identify clinical and microbi…
View article: 2164. Resistome patterns associated with vancomycin non-susceptibility in clinical <i>Clostridioides difficile</i> isolates
2164. Resistome patterns associated with vancomycin non-susceptibility in clinical <i>Clostridioides difficile</i> isolates Open
Background Clostridioides difficile exhibits phenotypic resistance to multiple classes of antibiotics. Associated antibiotic resistance genes (ARGs) are commonly transferred via mobile genetic elements, which often carry distinct ARG group…
View article: 702. Efficacy of Fecal Microbiota, Live-jslm After Receipt of Non–Clostridioides difficile Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Trial
702. Efficacy of Fecal Microbiota, Live-jslm After Receipt of Non–Clostridioides difficile Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Trial Open
Background Live biotherapeutic products (LBPs) are adjunctive therapies to prevent recurrence of Clostridioides difficile infection (CDI). In this post hoc subgroup analysis, the durability of fecal microbiota, live-jslm (REBYOTA™; abbrevi…
View article: Detectable Vancomycin Stool Concentrations in Hospitalized Patients with Diarrhea Given Intravenous Vancomycin
Detectable Vancomycin Stool Concentrations in Hospitalized Patients with Diarrhea Given Intravenous Vancomycin Open
Vancomycin is not appreciably passaged via the colonic membrane to the gastrointestinal (GI) tract in persons with an intact gut epithelium due to its large chemical structure. However; hospitalized patients with diarrhea often have a disr…
View article: The Significance of Bayesian Pharmacokinetics in Dosing for Critically Ill Patients: A Primer for Clinicians Using Vancomycin as an Example
The Significance of Bayesian Pharmacokinetics in Dosing for Critically Ill Patients: A Primer for Clinicians Using Vancomycin as an Example Open
Antibiotic use is becoming increasingly challenging with the emergence of multidrug-resistant organisms. Pharmacokinetic (PK) alterations result from complex pathophysiologic changes in some patient populations, particularly those with cri…
View article: ICE volume 44 issue 9 Cover and Front matter
ICE volume 44 issue 9 Cover and Front matter Open
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View article: Decoding a cryptic mechanism of metronidazole resistance among globally disseminated fluoroquinolone-resistant Clostridioides difficile
Decoding a cryptic mechanism of metronidazole resistance among globally disseminated fluoroquinolone-resistant Clostridioides difficile Open
View article: Gut microbiota changes associated with <i>Clostridioides difficile</i> infection and its various treatment strategies
Gut microbiota changes associated with <i>Clostridioides difficile</i> infection and its various treatment strategies Open
Human gut microbiota are critical to both the development of and recovery from Clostridioides difficile infection (CDI). Antibiotics are the mainstay of CDI treatment, yet inherently cause further imbalances in the gut microbiota, t…
View article: Redefining Clostridioides difficile infection antibiotic response and clinical outcomes
Redefining Clostridioides difficile infection antibiotic response and clinical outcomes Open
View article: Surveillance of <i>Clostridioides difficile</i> Antimicrobial Resistance in the United States
Surveillance of <i>Clostridioides difficile</i> Antimicrobial Resistance in the United States Open
Journal Article Surveillance of Clostridioides difficile Antimicrobial Resistance in the United States Get access Anne J Gonzales-Luna, Anne J Gonzales-Luna Department of Pharmacy Practice and Translational Research, University of Houston …
View article: Preservation of the Innate Immune Response to<i>Clostridioides difficile</i>Infection in Hospitalized Immunocompromised Patients
Preservation of the Innate Immune Response to<i>Clostridioides difficile</i>Infection in Hospitalized Immunocompromised Patients Open
Background Clostridioides difficile infection (CDI) immune response is influenced by the innate and adaptive (humoral) immune systems. Our prior research found attenuated humoral responses to C difficile in immunocompromised hosts (ICHs) w…
View article: Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109
Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109 Open
Importance Recurrent Clostridioides difficile infection (CDI) is a debilitating disease leading to poor health-related quality of life (HRQOL), loss of productivity, anxiety, and depression. The potential association of treatment with HRQO…
View article: Emerging Options for the Prevention and Management of Clostridioides difficile Infection
Emerging Options for the Prevention and Management of Clostridioides difficile Infection Open
View article: Baseline stool toxin concentration is associated with risk of recurrence in children with <i>Clostridioides difficile</i> infection
Baseline stool toxin concentration is associated with risk of recurrence in children with <i>Clostridioides difficile</i> infection Open
Background: In adults with Clostridioides difficile infection (CDI), higher stool concentrations of toxins A and B are associated with severe baseline disease, CDI-attributable severe outcomes, and recurrence. We evaluated whether toxin co…
View article: Clinical characteristics, microbiology and outcomes of a cohort of patients treated with ceftolozane/tazobactam in acute care inpatient facilities, Houston, Texas, USA
Clinical characteristics, microbiology and outcomes of a cohort of patients treated with ceftolozane/tazobactam in acute care inpatient facilities, Houston, Texas, USA Open
Background Ceftolozane/tazobactam is a β-lactam/β-lactamase inhibitor combination with activity against a variety of Gram-negative bacteria, including MDR Pseudomonas aeruginosa. This agent is approved for hospital-acquired and ventilator-…