Efficacy and safety of ceftazidime/avibactam in patients with infections caused by β-lactamase-producing Gram-negative pathogens: a pooled analysis from the Phase 3 clinical trial programme.

Objectives: This post hoc pooled analysis evaluated clinical and microbiological outcomes and safety in patients with infections caused by β-lactamase-producing Gram-negative pathogens across five Phase 3, randomized, controlled, multicentre trials of ceftazidime/avibactam in adults with complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI)/pyelonephritis and nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP).

Methods: In each trial, RECLAIM/RECLAIM 3 (cIAI), REPRISE (cIAI/cUTI), RECAPTURE (cUTI) and REPROVE (NP, including VAP) patients were randomized 1:1 to IV ceftazidime/avibactam (plus metronidazole for patients with cIAI) or comparators (carbapenems in >97% patients) for 5-21 days. Clinical and microbiological responses at the test-of-cure visit were assessed for patients with ESBLs, and/or plasmidic and/or overexpression of chromosomal AmpC, and/or serine carbapenemases without MBLs identified in baseline Gram-negative isolates by phenotypic screening and molecular characterization in the pooled microbiological modified ITT (mMITT) population.

Antimicrobial Susceptibility Among Gram-Negative Isolates in Pediatric Patients in Latin America, Africa-Middle East, and Asia From 2016-2020 Compared to 2011-2015: Results From the ATLAS Surveillance Study.

Background: Antimicrobial resistance (AMR) data in the pediatric population are limited, particularly in developing countries. This study assessed the AMR profile and key resistance phenotypes and genotypes for Gram-negative bacteria (GNB) isolates collected as part of the Antimicrobial Testing Leadership and Surveillance program from pediatric patients in Latin America, Africa-Middle East, and Asia in 2016-2020 versus 2011-2015.

Methods: Minimum inhibitory concentrations by broth microdilution methodology were interpreted per the Clinical and Laboratory Standards Institute.

Calcium Carbonate Coating of 3D-Printed PLA Scaffolds Intended for Biomedical Applications.

The incorporation of ceramic additives is the most commonly used strategy to improve the biofunctionality of polymer-based scaffolds intended for bone regeneration. By embedding ceramic particles as a coating, the functionality improvement in the polymeric scaffolds can be concentrated on the cell-surface interface, thus creating a more favourable environment for the adhesion and proliferation of osteoblastic cells. In this work, a pressure-assisted and heat-induced method to coat polylactic acid (PLA) scaffolds with calcium carbonate (CaCO) particles is presented for the first time.

In vitro activity of ceftazidime-avibactam against Enterobacterales and Pseudomonas aeruginosa isolates collected in Latin America as part of the ATLAS global surveillance program, 2017-2019.

The Antimicrobial Testing Leadership and Surveillance (ATLAS) global surveillance program collected clinical isolates of Enterobacterales (n = 8416) and Pseudomonas aeruginosa (n = 2521) from 41 medical centers in 10 Latin American countries from 2017 to 2019. In vitro activities of ceftazidime-avibactam and comparators were determined using the Clinical and Laboratory Standards Institute (CLSI) broth microdilution method. Overall, 98.

Influence of Environmental and Productive Factors on the Biodiversity of Lactic Acid Bacteria Population from Sheep Milk.

Milk is a typical and satisfactory medium for the growth of lactic acid bacteria (LAB). These microorganisms are of vital importance in the quality of the milk since they contribute to its preservation and give differential organoleptic properties to the final product. Furthermore, LABs can act as biocontrol agents in the dairy industry by inhibiting the growth of undesirable bacteria present in milk and by improving the quality of dairy products such as cheese.

Modeling the potential impact of administering vaccines against Clostridioides difficile infection to individuals in healthcare facilities.

Background: A vaccine against Clostridioides difficile infection (CDI) is in development. While the vaccine has potential to both directly protect those vaccinated and mitigate transmission by reducing environmental contamination, the impact of the vaccine on C. difficile colonization remains unclear.

Dominant Yeast Community in Raw Sheep's Milk and Potential Transfers of Yeast Species in Relation to Farming Practices.

Yeasts are always present in any type of cheese, as well as in the factories where it is produced. However, the role of the yeast community in the cheese making process, as well as the routes of contamination used by yeast species to contaminate milk from the dairy farm environment, are not well known. The objectives of this study were to broaden the knowledge of the dominant yeast community in Manchega sheep's milk and to assess the contamination routes of the yeast species depending on the farm practices.

Factors Affecting Levels of Airborne Bacteria in Dairy Farms: A Review.

This review attempts to reflect the importance of different factors that affect the environmental quality of dairy farms and must, therefore, be taken into account when considering the importance of environmental microbiology as a tool in the improvement of the quality of milk and dairy products. The effect of a factor such as temperature is vital for the dairy farm environment, especially when the temperatures are extreme, because a proper choice of temperature range improves the quality of the air and, thus, animal welfare. Similarly, the appropriate level of relative humidity in the environment should be taken into consideration to avoid the proliferation of microorganisms on the farm.

High Burden of Among Native American Individuals on the White Mountain Apache Tribal Lands.

Background: This study was done to determine the burden of invasive on the White Mountain Apache Tribal lands.

Methods: Active population and laboratory-based surveillance for invasive infections was conducted from May 2016 to April 2018. A case was defined as a Native American individual living on or around the White Mountain Apache Tribal lands with isolated from a normally sterile body site.

The burden of Staphylococcus aureus among Native Americans on the Navajo Nation.

Introduction: Native Americans in the southwestern United States have a higher risk for many infectious diseases and may be at higher risk for Staphylococcus aureus due to the high prevalence of risk factors for S. aureus. Recent data on invasive S.

Efficacy of intravenous tigecycline in patients with complex infections: results from 14 Phase III and Phase IV clinical trials.

Background: infections, especially multidrug-resistant (MDR) infections, are a global health problem. This study aimed to describe clinical outcomes in patients with confirmed spp. isolates who were treated with tigecycline in randomized clinical trials.

Value of Propensity Score Matching for Equalizing Comparator Groups in Observational Database Studies: A Case Study in Anti-infectives.

Purpose: Propensity score methodologies can reduce bias and confounding in nonrandomized studies, including pharmaceutical comparative effectiveness studies. An observational case study was developed to demonstrate the impact of propensity score adjustments on outcomes (ie, discharge status) of patients hospitalized for complicated intra-abdominal infections.

Methods: Two cohorts were examined: intensive care unit (ICU) (vs non-ICU) patients and tigecycline-treated patients (vs patients receiving other antibiotics).

Evaluation of Tigecycline Efficacy and Post-Discharge Outcomes in a Clinical Practice Population with Complicated Intra-Abdominal Infection: A Propensity Score-Matched Analysis.

Background: The utility of tigecycline as compared with other antibiotic therapies in the treatment of patients with complicated intra-abdominal infection (cIAI) and the short- and long-term outcomes of a large cohort of severely ill patients were examined. We provide the first published data on post-discharge events for these patients.

Methods: Retrospective data for the cIAI cohort were obtained from a large clinical database.

Clinical response and mortality in tigecycline complicated intra-abdominal infection and complicated skin and soft-tissue infection trials.

An imbalance in all-cause mortality was noted in tigecycline phase 3 and 4 comparative clinical trials across all studied indications. We investigated clinical failure and mortality in phase 3 and 4 complicated skin and soft-tissue infection (cSSTI) and complicated intra-abdominal infection (cIAI) tigecycline trials using descriptive analyses of a blinded adjudication of mortality and multivariate regression analyses. Attributable mortality analyses of cSSTI revealed death due to infection in 0.

Methicillin-resistant Staphylococcus aureus infection epidemiology and clinical response from tigecycline soft tissue infection trials.

Given increasing resistance, therapeutic options to treat MRSA soft tissue infections should be evaluated. This pooled analysis evaluated data from subjects enrolled in 6 tigecycline clinical trials with documented MRSA complicated skin and skin structure infections or diabetic foot infections (DFIs). Baseline characteristics were compared between subjects with and without molecularly classified community-acquired (CA) MRSA, specifically staphylococcal cassette chromosome mec (SCCmec) IV.

Pancreatitis in tigecycline Phase 3 and 4 clinical studies.

Objectives: To examine the incidence of pancreatitis among subjects enrolled in the tigecycline clinical trial programme, summarize cases and examine concomitant use of other pancreatitis-causing medications.

Methods: Subject data from Phase 3 and 4 comparative tigecycline studies were included in the analysis; investigator-reported adverse events of 'pancreatitis', 'necrotizing pancreatitis' or 'pancreas disorder' were reviewed. Data were summarized and cases were reported.

Comparative activity of carbapenem testing: the COMPACT study.

Objectives: Doripenem is a new carbapenem recently introduced into Europe. The COMParative Activity of Carbapenem Testing (COMPACT) study compared the susceptibility of common Gram-negative bacilli causing serious infections in hospitalized patients with doripenem, imipenem and meropenem.

Methods: Gram-negative isolates (4498 total: 2171 Pseudomonas species; 1910 Enterobacteriaceae; and 417 other Gram-negative bacilli) were collected from 80 centres in 16 countries in Europe, the Middle East and Africa during 2008-09.

Comparative activity of ceftobiprole against Gram-positive and Gram-negative isolates from Europe and the Middle East: the CLASS study.

Objectives: to assess the in vitro activity of ceftobiprole and comparators against a recent collection of Gram-positive and Gram-negative pathogens, in order to detect potential changes in susceptibility patterns, and to evaluate the Etest assay for ceftobiprole susceptibility testing.

Methods: contemporary Gram-positive and Gram-negative isolates (excluding extended-spectrum β-lactamase-producing isolates) from across Europe and the Middle East were collected, and their susceptibility to ceftobiprole, vancomycin, teicoplanin, linezolid, ceftazidime and cefepime was assessed using the Etest method. Quality testing [using Etest and broth microdilution (BMD)] was conducted at a central reference laboratory.

Medical resource utilization among patients with ventilator-associated pneumonia: pooled analysis of randomized studies of doripenem versus comparators.

Introduction: Ventilator-associated pneumonia (VAP) is associated with increased medical resource utilization, but few randomized studies have been conducted to evaluate the effect of initial antibiotic therapy. To assess medical resource utilization in patients with VAP, we conducted a pooled analysis of two prospective, randomized, open-label, multicenter, phase III studies, which also showed that doripenem was clinically noninferior to comparators.

Methods: We assessed durations of mechanical ventilation, intensive care unit (ICU) stay, and hospitalization in patients with VAP who received at least 1 dose of doripenem or a comparator in the phase III studies.

Outcomes associated with initial versus later vancomycin use in patients with complicated skin and skin-structure infections.

Background: Delayed coverage of pathogens including meticillin-resistant Staphylococcus aureus (MRSA) in pneumonia and bacteraemia has been associated with increased mortality and length of hospital stay (LOS). However, less is known about the impact of delayed appropriate coverage in complicated skin and skin-structure infections (cSSSIs).

Objective: To evaluate the clinical and economic outcomes associated with early versus late use of vancomycin in the management of patients hospitalized for cSSSIs.

Hospital resource utilization with doripenem versus imipenem in the treatment of ventilator-associated pneumonia.

Background: Ventilator-associated pneumonia (VAP) is a common nosocomial infection that is associated with prolonged length of stay (LOS) and significant mortality.

Objective: The aim of this study was to compare resource utilization with doripenem, an investigational carbapenem, versus imipenem from a hospital perspective among patients with VAP.

Methods: This analysis was based on data from a Phase III, randomized, open-label, noninferiority study that compared clinical cure of VAP with doripenem 500 mg q8h i.