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Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - A stakeholder meeting report.
Biologicals
January 2025
Centre for Human Drug Research (CHDR), Leiden, the Netherlands; Leiden University Medical Center (LUMC), Leiden, the Netherlands.
Inno4Vac, a public-private partnership funded by the IMI2/EU/EFPIA Joint Undertaking (IMI2 JU), brings together academic institutions, SMEs, and pharmaceutical companies to accelerate and de-risk vaccine development. The project has made significant strides in the selection and production of challenge agents for influenza, respiratory syncytial virus (RSV), and toxigenic Clostridioides difficile for controlled human infection model studies (CHIMs). A regulatory workshop held on March 20, 2024, addressed the standardisation of clinical procedures, ethical considerations, endpoints, and data integrity, highlighting the ongoing initiatives related to these CHIMs.
View Article and Find Full Text PDFEffectiveness of oral vancomycin as prophylaxis against infection in hematopoietic stem cell transplant patients.
Antimicrob Steward Healthc Epidemiol
August 2024
Department of Pharmacy, Robert Wood Johnson University Hospital, New Brunswick, NJ, USA.
Objective: Patients receiving hematopoietic stem cell transplants (HSCT) are at increased risk for infection (CDI). The purpose of this study was to assess the effectiveness of oral vancomycin prophylaxis (OVP) for CDI in HSCT patients.
Design: Single-center, retrospective cohort.
The economic burden of post-endoscopic retrograde cholangiopancreatography (ERCP) procedure infections in Italy.
Glob Reg Health Technol Assess
December 2024
Department of Hospital Pharmacy, Città della Salute e della Scienza di Torino, Turin - Italy.
Introduction: The infections of multidrug-resistant organisms (MDROs) associated with duodenoscopes during endoscopic retrograde cholangiopancreatography (ERCP) procedure have become a significant cause for concern, especially in fragile patients. While the clinical impacts of these infections are well-documented, their economic implications remain underexplored. This study assesses the incidence and economic burden of post-ERCP infections in Italy using an administrative database.
View Article and Find Full Text PDFManagement of Recurrent Clostridioides difficile Infection (rCDI): A Systematic Literature Review to Assess the Feasibility of Indirect Treatment Comparison (ITC).
Infect Dis Ther
January 2025
Global Research and Medical, Ferring Pharmaceuticals, Kastrup, Denmark.
Recurrent Clostridioides difficile infection (rCDI) is a major cause of increased morbidity, mortality, and healthcare costs. Fecal-microbiota-based therapies are recommended for rCDI on completion of standard-of-care (SoC) antibiotics to prevent further recurrence: these therapies include conventional fecal-microbiota transplantation and the US Food and Drug Administration-approved therapies REBYOTA® (RBL) and VOWST Oral Spores™ (VOS). As an alternative to microbiota-based therapies, bezlotoxumab, a monoclonal antibody, is used as adjuvant to SoC antibiotics to prevent rCDI.
View Article and Find Full Text PDFThe evolving landscape of live biotherapeutics in the treatment of Clostridioides difficile infection.
Indian J Gastroenterol
January 2025
Division of Gastroenterology and Hepatology, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.
Clostridioides difficile (C. difficile) infection (CDI) is common after antibiotic exposure and presents significant morbidity, mortality and healthcare costs worldwide. The rising incidence of recurrent CDI, driven by hypervirulent strains, widespread antibiotic use and increased community transmission, has led to an urgent need for novel therapeutic strategies.
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