28 Clinical Trials for Various Conditions
The aims of this project, called "Surveillance of Healthcare-associated infections \& Antimicrobial Resistance", or "SHARE", are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs to use data to prevent, detect, and contain emerging AMR threats; 3) deploy study teams to answer critical public health surveillance questions, and 4) to build a national network of infection prevention and control (IPC) resources to prevent, detect, and contain emerging infectious disease threats
The purpose of the research is to find out the effect of commonly used topical antibiotics on the bacteria that live in the nose, throat and on the skin of older adults. In addition, the investigators want to determine if these topical antibiotics affect how bacteria are spread in Community Living Centers of the VA Maryland Health Care System.
The central hypothesis is that daily dental xylitol wipes, in addition to current oral care practice, are effective at reducing BSI from oral organisms, and decreasing the incidence of gingivitis, oral plaque, and oral ulcerations after SCT.
The objective is to conduct a prospective, sham controlled, double-blinded, interventional crossover trial to compare standard terminal cleaning plus PX-UV (intervention) with standard terminal cleaning plus sham PX-UV (control) with crossover at 12 months, following a 6-month washout period. Outcome measures include the rates of HAIs, as well as the recurrence of genetically identical clinical strains of HAIs among patients on study units. The study will be conducted in 2 hospitals covering 16 total hospital units at Detroit Medical Center. Our central hypothesis is that the addition of PX-UV to standard terminal cleaning will be associated with a significant reduction in the rate of HAIs, as well as a reduction in the recovery of genetically identical strains of MDROs. The impact of PX-UV disinfection on rates of HAIs on study units will be determined by comparing rates of HAIs on a) study units where PX-UV is added to standard terminal cleaning practices to b) units where a sham UV disinfection system is added to standard terminal cleaning; and by comparing rates of HAIs on the same medical ward during each of two 12-month phases of a crossover study (one phase when a PX-UV device is added and one when a sham device is added to standard terminal cleaning). The long-term goal of this project is to establish the efficacy of terminal cleaning plus PX-UV in reducing rates of HAIs due to the following multi-drug resistant organisms (MDROs): C. difficile, vancomycin-resistant enterococci (VRE), Klebsiella pneumoniae and Escherichia coli producing extended-spectrum beta-lactamases (ESBLs), methicillin-resistant Staphylococcus aureus (MRSA) and Acinetobacter baumannii. At the conclusion of the proposed project, novel data will be generated from this rigorously controlled study regarding the effectiveness of PX-UV in reducing HAIs in a representative, real-world healthcare setting.
This is a prospective Infection Control study comparing rates of antibiotic usage and infections in the General Intensive Care Unit (GICU) in beds with copper impregnated linens versus regular linens.
Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for the prevention of healthcare-associated infections (HAIs) due to selected multidrug-resistant (MDR) bacterial pathogens. The investigators will perform a large prospective, multicenter study enhanced terminal room disinfection to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.
The purpose of this study is to determine whether Kerlix AMD gauze will decrease the incidence of healthcare associated infections in burn patients. Kerlix AMD gauze will be applied to all patients with open wounds admitted to the burn unit during the prospective portion of the study. All consenting patients will be assessed for hospital associated infections and outcomes. We hypothesis that burn patients will have a decreased number of hospital associated infections compared to historical controls.
The goal of this clinical trial is to evaluate the potential effects of photobiomodulation when used with topical disinfectants in the anterior nares of healthy adults. Over a three week period, participants will have their anterior nares swabbed with methylene blue, chlorhexidine gluconate, or a combination of the two followed by 4 minutes of non-thermal red light treatment. The fourth week of consist of only red light treatment. Culture samples of the subjects nasal microbiome will be taken prior to treatment, immediately after treatment, 4-, 8-, 24-, and 48 hours after treatment.
Substantial center variability exists in healthcare-associated infection (HAI) rates following durable ventricular assist device (VAD) implantation for patients with advanced heart failure. Preliminary evidence suggests that this variability may be related to process (e.g., pre-operative intranasal mupirocin), provider (e.g., surgeon technique, physician teamwork), device, (e.g., centrifugal vs. axial flow), and center specific (e.g., infection prevention strategies and resources) factors. The investigators will undertake a mixed methods study to: (1) identify determinants of center-level variability in HAI rates, (2) develop a comprehensive understanding of barriers and facilitators for achieving low center HAI rates, and (3) develop, iteratively enhance, and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts.
Our Aim is to identify patient risk factors and clinical practices associated with healthcare-acquired infections (HAIs) after cardiac surgery. We will use prospectively collected data housed within the MSTCVS-QC (Michigan Society of Thoracic \& Cardiovascular Surgeons Quality Collaborative) to reveal risk factors that elevate a patient's risk of developing HAIs. The results of this analysis will form the foundation for the development of standardized regional practices to reduce HAIs. We will explore the effect of traditional patient-level measures (age, sex, comorbid conditions), process measures (timing and selection of antibiotics, continuous insulin infusion, transfusions), and surgical practices (use of bilateral internal mammary artery usage among diabetics, vein harvesting approach).
The ABATE Infection Project is a cluster randomized trial of hospitals to compare two quality improvement strategies to reduce multi-drug resistant organisms and healthcare-associated infections in non-critical care units. The two strategies to be evaluated are: * Arm 1: Routine Care Routine policy for showering/bathing * Arm 2: Decolonization Use of chlorhexidine as routine soap for showering or bed bathing for all patients Mupirocin x 5 days if MRSA+ by history, culture, or screen Note that enrolled "subjects" represents 53 individual HCA Hospitals (representing \~190 non-critical care units) that have been randomized.
Healthcare-associated infections are a major cause of morbidity among critically ill patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections. The purpose of this study is to evaluate the effect of daily bathing with disposable chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated infections in critically-ill patients. Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will result in reduced rates of healthcare-associated infections in patients admitted to intensive care units (ICU).
The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent. The study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap. The primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome.
The goal of this observational study is to facilitate standardized nontuberculous mycobacteria (NTM) outbreak investigations in healthcare centers. The main questions it aims to answer are: * Are respiratory NTM isolates identified as having membership in a suspected healthcare outbreak highly related based on whole genome sequencing? * Does epidemiologic investigation support healthcare-associated patient-to-patient NTM transmission? * Does healthcare environmental sampling support healthcare-associated NTM acquisition? If healthcare-associated NTM outbreaks are suspected, participants identified as having membership in a cluster of highly-related NTM infections will complete a demographic questionnaire.
Geographic Information Systems (GIS) and spatial analysis have become important tools in public health informatics but have rarely been applied to the hospital setting. In this study we apply these tools to address the challenge of Hospital Acquired Infections (HAIs) by building, implementing, and evaluating a new computer application which incorporates mapping and geographic data to assist hospital epidemiologists in identifying HAI clusters and assessing transmission risk. We expect that incorporation of geographic information into the workflow of hospital epidemiologists will have a profound effect on our understanding of disease transmission and HAI risk factors in the hospital setting, radically altering the workflow and speed of response of infection preventionists and improving their ability to prevent HAIs.
This is a Phase 2 single-center, open-label, single-arm, study of a microbiological endpoint using antimicrobial photodynamic therapy (aPDT) for nasal disinfection in all patients (universal) presenting for surgery at an acute care hospital for a wide range of surgical procedures.
Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2. This study will enroll 470 healthcare professionals dedicated to care for patients with proven SARS-CoV-2 infection. Subjects will be randomized either in the observational (control) group or in the inhaled nitric oxide group. All personnel will observe measures on strict precaution in accordance with WHO and the CDC regulations.
This is a prospective multi-center study. Bacterial isolates from hospitalized patients with CA-HRE will be compared to those from hospitalized patients with healthcare-associated HRE (HA-HRE). In addition, community spread of CRE will be determined.
Annually, more than 250,000 patients in the U.S. with end-stage heart failure stand to benefit from ventricular assist device (VAD) therapy. 60% of patients develop a healthcare-associated infection (HAI) within 90-days of implantation. The investigators long term goal is to develop and subsequently promote wide-scale adoption of evidence-based HAI prevention practices following durable VAD implantation. This will be done by addressing the following aims: Aim 1. Identify determinants of center-level variability in HAI rates. Aim 2. Develop a comprehensive understanding of barriers and facilitators for achieving low center HAI rates. Aim 3. Develop, iteratively enhance, and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts. The investigators will use a focused survey of U.S. VAD centers to identify determinants of center variation in 90-day HAI rates: * Process Factors (e.g., intranasal mupirocin), * Provider Factors (e.g., surgeon technique), * Device Factors (e.g., centrifugal vs. axial), * Center Factors (e.g., provider communication). Understanding the barriers and facilitators within individual centers for maximizing adoption of prevention measures would serve as the foundation for targeted improvement strategies. Without this knowledge, evidence-based, action-oriented recommendations will have limited local adoption and ultimately effectiveness in preventing HAIs after VAD implantation.
This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that uses a digital microscope to identify bacteria based on their growth patterns. This method does not have to wait for bacteria to grow in a lab. The new method can identify the type of bacteria within 2 hours of receiving a specimen. The new method also shows the effect of selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors know within 6 hours from specimen collection which antibiotic kills the bacteria. To check the accuracy, speed and impact of the new method on antibiotic prescribing, investigators are proposing a study with two parts; The first part will test the accuracy and speed of the results obtained by the new method. The second part will test if having the results from the new method early would change the antibiotics prescribed to a patient in a simulation experiment. An independent infectious disease physician will be shown the results from the new method and asked if the results were accurate, would it change the antibiotic treatment for the patient.
The investigators will conduct qualitative interviews of hospital personnel regarding HAI prevention practices, and use coded data from these interviews to assist in developing standardized practices.
Military service members and the U.S. veteran population face a growing and serious health threat: widespread antibiotic resistance resulting from resistant bacteria and a dwindling pipe-line of sufficiently potent antibiotics. Infections with antibiotic resistant bacteria are increasing significantly. They cause major complications and mortality, and drive up healthcare costs. Powerful but non-targeted antibiotics, while in widespread use, can actually pressure bacteria to develop resistance.
The Swap Out Trial is a cluster randomized controlled trial of HCA hospitals, evaluating the non-inferiority of two decolonization regimens: Arm 1 Routine Care: ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing; Arm 2 Intervention: ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing Note: that enrolled "subjects" represents 137 individual HCA Hospitals (representing \~235 ICUs) that have been randomized.
The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).
Pulmonary NTM infection is recognized as one of the most challenging infections to treat among people with cystic fibrosis (PwCF), notable for prolonged treatment courses and often poor response to therapy. Positive cultures for NTM occur in about 20% of children and adults with cystic fibrosis (CF). However, the source of NTM infection, modes of transmission, and exposure risks are poorly understood. It is thought that NTM is primarily acquired from environmental sites including soil and water as well as water supply systems to homes, hospitals, and clinics and from aerosols generated by flowing water from taps, showers, and fountains. Nonetheless, no direct molecular link has been established between environmental NTM and respiratory CF NTM. Healthcare-associated transmission of NTM among CF patients has been suspected and is of growing concern for CF Centers worldwide. Widespread global transmission of NTM, potentially via person-to-person transmission of fomites and aerosols has been reported. The parent HALT NTM study developed and published a standardized epidemiologic outbreak toolkit for investigation of healthcare-associated NTM outbreaks in CF Care Centers. We are now moving to a prospective investigation, with the long-term goal of real-time early identification and mitigation of potential NTM outbreak investigations coupled with healthcare environmental sampling and home of residence watershed analysis of PwCF identified as belonging to an NTM cluster and receiving care at a single CF Care Center.
Sources of NTM infection and modes of transmission among CF patients are poorly understood. Healthcare-associated transmission of NTM among CF patients has been suspected and is of growing concern for CF Centers. There is a need for a systematic evidence-based approach to investigating potential episodes of healthcare-associated transmission. Clusters of highly similar strains of NTM in CF patients cared for at the same CF Center may arise from healthcare sources including patient-to-patient transmission and/or acquisition from water sources within a healthcare setting. The primary objective of the study is to facilitate a standardized process by which CF Centers may perform data abstraction on patients identified with highly similar NTM isolates and determine if clustered NTM strains are related to strains isolated from healthcare setting water biofilm sources. HALT NTM is available to the entire CF Foundation Care Network, under a collaborative agreement, to initiate a standardized, independent, confidential, internal NTM outbreak investigation. Patients that are identified by whole genome sequencing as having highly similar NTM strains and receiving care in the same CF Care Center are eligible. The study's primary endpoint is to identify potential modes and sources of healthcare-associated acquisition of CF NTM, thereby revealing risk factors for NTM acquisition.
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.
Solid organ transplant (SOT) recipients have increased incidence of infections with MDRO pathogens. This difference leads to a disparity in antibiograms between SOT recipients and other hospitalized patients.