A phase III randomized controlled non-inferiority trial to study the efficacy and safety of imipenem/cilastatin/relebactam (IMI/REL) versus piperacillin/tazobactam (PIP/TAZ) in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).

Objectives: Imipenem/cilastatin/relebactam (IMI/REL) is a β-lactam/β-lactamase inhibitor combination effective against gram-negative pathogens. Efficacy and safety of IMI/REL were studied in critically ill adults with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).

Methods: In this phase III, double-blind, multinational, randomized trial (NCT03583333), adults with HABP/VABP were randomized 1:1 to receive intravenous IMI/REL (500 mg/250 mg) or piperacillin/tazobactam (PIP/TAZ; 4000 mg/500 mg) every 6 h for 7-14 days.

Virologic Response and Safety of Ibuzatrelvir, a Novel SARS-CoV-2 Antiviral, in Adults With COVID-19.

Background: Despite effective vaccines and treatments for COVID-19, clinical burden persists. An unmet need exists for additional effective agents with safety profiles allowing use across a broad population. Ibuzatrelvir is an orally bioavailable SARS-CoV-2 Mpro inhibitor that has demonstrated in vitro antiviral activity and low potential for safety concerns, including drug-drug interactions.

Pharmacokinetics, Safety, and Tolerability of Imipenem/Cilastatin/Relebactam in Children with Confirmed or Suspected Gram-Negative Bacterial Infections: A Phase 1b, Open-Label, Single-Dose Clinical Trial.

Imipenem/cilastatin/relebactam is approved for the treatment of serious gram-negative bacterial infections in adults. This study assessed the pharmacokinetics (PK), safety, and tolerability of a single dose of imipenem/cilastatin/relebactam (with a fixed 2:1 ratio of imipenem/cilastatin to relebactam, and with a maximum dose of 15 mg/kg imipenem and 15 mg/kg cilastatin [≤500 mg imipenem and ≤500 mg cilastatin] and 7.5 mg/kg relebactam [≤250 mg relebactam]) in children with confirmed/suspected gram-negative bacterial infections receiving standard-of-care antibacterial therapy.

Participant- and Disease-Related Factors as Independent Predictors of Treatment Outcomes in the RESTORE-IMI 2 Clinical Trial: A Multivariable Regression Analysis.

Background: In the RESTORE-IMI 2 trial, imipenem/cilastatin/relebactam (IMI/REL) was noninferior to piperacillin/tazobactam in treating hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. This post hoc analysis was conducted to determine independent predictors of efficacy outcomes in the RESTORE-IMI 2 trial, to assist in treatment decision making.

Methods: A stepwise multivariable regression analysis was conducted to identify variables that were independently associated with day 28 all-cause mortality (ACM), favorable clinical response at early follow-up (EFU), and favorable microbiologic response at end of treatment (EOT).

Imipenem/cilastatin/relebactam efficacy, safety and probability of target attainment in adults with hospital-acquired or ventilator-associated bacterial pneumonia among patients with baseline renal impairment, normal renal function, and augmented renal clearance.

Objectives: To assess the relationship between renal function and efficacy/safety of imipenem/cilastatin/relebactam for the treatment of hospital-acquired/ventilator-associated pneumonia (HABP/VABP) from RESTORE-IMI 2 and determine the PTA.

Methods: Adults with HABP/VABP were randomized 1:1 to IV imipenem/cilastatin/relebactam 1.25 g or piperacillin/tazobactam 4.

A Randomized, Double-blind, Multicenter Trial Comparing Efficacy and Safety of Imipenem/Cilastatin/Relebactam Versus Piperacillin/Tazobactam in Adults With Hospital-acquired or Ventilator-associated Bacterial Pneumonia (RESTORE-IMI 2 Study).

Background: Imipenem combined with the β-lactamase inhibitor relebactam has broad antibacterial activity, including against carbapenem-resistant gram-negative pathogens. We evaluated efficacy and safety of imipenem/cilastatin/relebactam in treating hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP).

Methods: This was a randomized, controlled, double-blind phase 3 trial.

Mycobacterium avium pseudo-outbreak associated with an outpatient bronchoscopy clinic: Lessons for reprocessing.

We identified a pseudo-outbreak of Mycobacterium avium in an outpatient bronchoscopy clinic following an increase in clinic procedure volume. We terminated the pseudo-outbreak by increasing the frequency of automated endoscope reprocessors (AER) filter changes from quarterly to monthly. Filter changing schedules should depend on use rather than fixed time intervals.

A prospective study of transmission of Multidrug-Resistant Organisms (MDROs) between environmental sites and hospitalized patients-the TransFER study.

Objective: Hospital environmental surfaces are frequently contaminated by microorganisms. However, the causal mechanism of bacterial contamination of the environment as a source of transmission is still debated. This prospective study was performed to characterize the nature of multidrug-resistant organism (MDRO) transmission between the environment and patients using standard microbiological and molecular techniques.

Enhanced disinfection leads to reduction of microbial contamination and a decrease in patient colonization and infection.

In this prospective study, we monitored 4 epidemiologically important pathogens (EIPs): methicillin-resistane Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), Clostridium difficile, and multidrug-resistant (MDR) Acinetobacter to assess the effectiveness of 3 enhanced disinfection strategies for terminal room disinfection against standard practice. Our data demonstrated that a decrease in room contamination with EIPs of 94% was associated with a 35% decrease in subsequent patient colonization and/or infection.

Effectiveness of targeted enhanced terminal room disinfection on hospital-wide acquisition and infection with multidrug-resistant organisms and Clostridium difficile: a secondary analysis of a multicentre cluster randomised controlled trial with crossover design (BETR Disinfection).

Background: The hospital environment is a source of pathogen transmission. The effect of enhanced disinfection strategies on the hospital-wide incidence of infection has not been investigated in a multicentre, randomised controlled trial. We aimed to assess the effectiveness of four disinfection strategies on hospital-wide incidence of multidrug-resistant organisms and Clostridium difficile in the Benefits of Enhanced Terminal Room (BETR) Disinfection study.

Implementation Lessons Learned From the Benefits of Enhanced Terminal Room (BETR) Disinfection Study: Process and Perceptions of Enhanced Disinfection with Ultraviolet Disinfection Devices.

OBJECTIVE To summarize and discuss logistic and administrative challenges we encountered during the Benefits of Enhanced Terminal Room (BETR) Disinfection Study and lessons learned that are pertinent to future utilization of ultraviolet (UV) disinfection devices in other hospitals DESIGN Multicenter cluster randomized trial SETTING AND PARTICIPANTS Nine hospitals in the southeastern United States METHODS All participating hospitals developed systems to implement 4 different strategies for terminal room disinfection. We measured compliance with disinfection strategy, barriers to implementation, and perceptions from nurse managers and environmental services (EVS) supervisors throughout the 28-month trial. RESULTS Implementation of enhanced terminal disinfection with UV disinfection devices provides unique challenges, including time pressures from bed control personnel, efficient room identification, negative perceptions from nurse managers, and discharge volume.

Real-Time Surveillance of Influenza Morbidity: Tracking Intensive Care Unit Resource Utilization.

Rationale: Existing real-time surveillance of influenza morbidity, based primarily on time-trended U.S. hospitalization and death data, is inadequate.

Identification of novel risk factors for community-acquired Clostridium difficile infection using spatial statistics and geographic information system analyses.

Background: The rate of community-acquired Clostridium difficile infection (CA-CDI) is increasing. While receipt of antibiotics remains an important risk factor for CDI, studies related to acquisition of C. difficile outside of hospitals are lacking.

Enhanced terminal room disinfection and acquisition and infection caused by multidrug-resistant organisms and Clostridium difficile (the Benefits of Enhanced Terminal Room Disinfection study): a cluster-randomised, multicentre, crossover study.

Background: Patients admitted to hospital can acquire multidrug-resistant organisms and Clostridium difficile from inadequately disinfected environmental surfaces. We determined the effect of three enhanced strategies for terminal room disinfection (disinfection of a room between occupying patients) on acquisition and infection due to meticillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, C difficile, and multidrug-resistant Acinetobacter.

Methods: We did a pragmatic, cluster-randomised, crossover trial at nine hospitals in the southeastern USA.

Two-Phase Hospital-Associated Outbreak of Mycobacterium abscessus: Investigation and Mitigation.

Background: Nontuberculous mycobacteria (NTM) commonly colonize municipal water supplies and cause healthcare-associated outbreaks. We investigated a biphasic outbreak of Mycobacterium abscessus at a tertiary care hospital.

Methods: Case patients had recent hospital exposure and laboratory-confirmed colonization or infection with M.

Effectiveness of ultraviolet devices and hydrogen peroxide systems for terminal room decontamination: Focus on clinical trials.

Over the last decade, substantial scientific evidence has accumulated that indicates contamination of environmental surfaces in hospital rooms plays an important role in the transmission of key health care-associated pathogens (eg, methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, Clostridium difficile, Acinetobacter spp). For example, a patient admitted to a room previously occupied by a patient colonized or infected with one of these pathogens has a higher risk for acquiring one of these pathogens than a patient admitted to a room whose previous occupant was not colonized or infected. This risk is not surprising because multiple studies have demonstrated that surfaces in hospital rooms are poorly cleaned during terminal cleaning.

Epidemiology of Surgical Site Infection in a Community Hospital Network.

Objective: To describe the epidemiology of complex surgical site infection (SSI) following commonly performed surgical procedures in community hospitals and to characterize trends of SSI prevalence rates over time for MRSA and other common pathogens

Methods: We prospectively collected SSI data at 29 community hospitals in the southeastern United States from 2008 through 2012. We determined the overall prevalence rates of SSI for commonly performed procedures during this 5-year study period. For each year of the study, we then calculated prevalence rates of SSI stratified by causative organism.

An Automated Surveillance Strategy to Identify Infectious Complications After Cardiac Implantable Electronic Device Procedures.

Background.  The optimum approach for infectious complication surveillance for cardiac implantable electronic device (CIED) procedures is unclear. We created an automated surveillance tool for infectious complications after CIED procedures.

Short Operative Duration and Surgical Site Infection Risk in Hip and Knee Arthroplasty Procedures.

Objective: To determine the association (1) between shorter operative duration and surgical site infection (SSI) and (2) between surgeon median operative duration and SSI risk among first-time hip and knee arthroplasties.

Design: Retrospective cohort study

Setting: A total of 43 community hospitals located in the southeastern United States.

Patients: Adults who developed SSIs according to National Healthcare Safety Network criteria within 365 days of first-time knee or hip arthroplasties performed between January 1, 2008 and December 31, 2012.

The Hawthorne Effect in Infection Prevention and Epidemiology.

The Hawthorne Effect is a prevalent observer effect that causes behavioral changes among participants of epidemiological studies or infection control interventions. The purpose of the review is to describe the origins of the Hawthorne Effect, to understand the term in relation to current scientific literature, to describe characteristics of the Hawthorne effect, and to discuss methods to quantify and overcome limitations associated with the Hawthorne Effect.

Seasonal Variation of Common Surgical Site Infections: Does Season Matter?

Objective: To evaluate seasonal variation in the rate of surgical site infections (SSI) following commonly performed surgical procedures.

Design: Retrospective cohort study.

Methods: We analyzed 6 years (January 1, 2007, through December 31, 2012) of data from the 15 most commonly performed procedures in 20 hospitals in the Duke Infection Control Outreach Network.

infections following knee and hip prosthesis insertion procedures.

Background: is the most common and most important pathogen following knee and hip arthroplasty procedures. Understanding the epidemiology of invasive infections is important to quantify this serious complication.

Methods: This nested retrospective cohort analysis included adult patients who had undergone insertion of knee or hip prostheses with clean or clean-contaminated wound class at 11 hospitals between 2003-2006.

Postoperative infection in spine surgery: does the month matter?

Object: The relationship between time of year and surgical site infection (SSI) following neurosurgical procedures is poorly understood. Authors of previous reports have demonstrated that rates of SSI following neurosurgical procedures performed during the summer months were higher compared with rates during other seasons. It is unclear, however, if this difference was related to climatological changes or inexperienced medical trainees (the July effect).