Ther Innov Regul Sci
March 2025
A data monitoring committee (DMC) can have an extremely challenging job. Stop a trial too soon, and results are inconclusive and the trial fails to obtain answers to important questions that could inform future clinical practice. Stop a trial too late, and trial participants are exposed to potentially harmful or ineffective interventions longer than necessary.
View Article and Find Full Text PDFBackground: Use of anti-carbapenem-resistant Enterobacterales (anti-CRE) agents such as ceftazidime/avibactam has been associated with improved clinical outcome in cohorts that primarily include patients infected with CRE that are resistant to meropenem (MCRE).
Objectives: To clarify whether patients with CRE resistant to ertapenem but susceptible to meropenem (ertapenem-only-resistant Enterobacterales; EORE) benefit from therapy with anti-CRE agents.
Methods: Patients treated for CRE infection in hospitals in the USA between 2016 and 2019 and enrolled in the CRACKLE-2 study were included.
Research data sharing has become an expected component of scientific research and scholarly publishing practice over the last few decades, due in part to requirements for federally funded research. As part of a larger effort to better understand the workflows and costs of public access to research data, this project conducted a high-level analysis of where academic research data is most frequently shared. To do this, we leveraged the DataCite and Crossref application programming interfaces (APIs) in search of Publisher field elements demonstrating which data repositories were utilized by researchers from six academic research institutions between 2012-2022.
View Article and Find Full Text PDFRapid detection of carbapenemase (KPC) in the species is desirable. The MALDI Biotyper MBT Subtyping Module (Bruker Daltonics) uses an algorithm that detects a peak at ~11,109 m/z corresponding to a protein encoded by the gene to detect KPC simultaneously with organism identification by a matrix-assisted laser desorption ionization-time-of-flight mass spectrometry (MALDI-ToF MS). Here, the subtyping module was evaluated using 795 clinical isolates, with whole genome sequences used to assess for and .
View Article and Find Full Text PDFBackground: Carbapenem-resistant Pseudomonas aeruginosa (CRPA) is a global threat, but the distribution and clinical significance of carbapenemases are unclear. The aim of this study was to define characteristics and outcomes of CRPA infections and the global frequency and clinical impact of carbapenemases harboured by CRPA.
Methods: We conducted an observational, prospective cohort study of CRPA isolated from bloodstream, respiratory, urine, or wound cultures of patients at 44 hospitals (10 countries) between Dec 1, 2018, and Nov 30, 2019.