Clinical Research Directory

British Columbia Prescriber Feedback Program - Antimicrobial Resistance

The goal of this study is to evaluate an educational intervention that aims to reduce the number of unnecessary antibiotics prescribed by family physicians and nurse practitioners in British Columbia, Canada. The intervention materials include a confidential personalized prescribing "portrait" and an evidence-based educational summary (therapeutics letter), accompanied by an introduction letter. The main research questions are: 1. Will the intervention lead to a reduction in the overall number of antibiotics prescriptions started? 2. Will the intervention lead to a reduction in the proportion of antibiotics prescribed that are likely unnecessary, especially prescriptions for upper respiratory tract infections, acute bronchitis, acute sinusitis? Researchers will conduct an intervention study with family physicians and nurse practitioners in British Columbia, Canada. Participant clinicians will be randomly assigned to one of two groups. The Early Group will consist of 80% of the participants and will receive the intervention (prescribing portrait, evidence summary, and introduction letter) at the start of the study. The Delayed Group will consist of 20% of participants and will receive the intervention about nine months later. This study design allows most practitioners to receive the intervention early while still allowing time to compare the two groups to assess the impact. To estimate the impact of the intervention, researchers will use administrative health data to compare the prescribing of the Early Group with prescribing of the Delayed Group.

Cocreating Action to Improve Rationality in the Health System

Despite widespread recognition of social, economic, or environmental health determinants, health action remains heavily dominated by individual-level solutions (e.g., medication, patient counselling, vaccination). This study aims to stimulate changes in health system functioning by demonstrating how the cocreation of actions to address psychological well-being, cardiovascular health, and antimicrobial resistance from within the community can alleviate the burden on primary care services, reduce medicalisation and increase health equity. The scientific approach uses mixed methods and incorporates theory from multiple disciplines. This study will appraise how the current system addresses psychological well-being, cardiovascular (CV) health, and rational use of antibiotics using a population survey, a survey of patients collecting their medication at community pharmacies, aggregate health service indicators on medication consumption and primary care consultations, and qualitative methods exploring stakeholders' perceptions.The investigators will undertake community-based participatory research to engage citizen scientists in the cocreation of community-led actions to promote psychological well-being, CV health, and prevent antimicrobial resistance. The design, implementation, and evaluation of the actions will apply an assets-based approach and apply theories and frameworks from implementation science in an iterative manner over 3 years. Finally, the impact of the cocreated actions will be analysed, considering effectiveness and broader contextual issues such as initiative adoption, implementation, and maintenance. The investigators will use a before-after comparison of survey indicators, an interrupted time-series analysis of health service data and qualitative analysis. The goal is to demonstrate how the integration of community action with attention to the social determinants of health, can lead to a more rational approach to health care and ultimately improve health and health equity.

A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers.

Cefiderocol vs Best Available Therapy for Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex Infections: A Target Trial Emulation

This study aims to compare 28-day mortality among patients with carbapenem resistant A. baumannii infections in two hypothetical target trials where patients receive 7 days of a cefiderocol-based treatment strategy or 7 days of a best available therapy treatment strategy.

Peer Comparison Feedback As An Antimicrobial Prescribing Intervention To General Medicine Specialists

The purpose of this study is to evaluate the effect of a peer comparison feedback report, combined with a best practices toolkit, on the volume of antimicrobial use by general medicine physicians. The study also aims to understand the qualitative and quantitative impact of peer comparison feedback on antimicrobial prescribing in hospital. This study will leverage data from GEMINI, a hospital research collaborative that collects administrative and clinical data from 30+ Ontario hospitals, to create these peer comparison feedback reports.

A Study of the Impact of Penicillin Allergy on Antimicrobial Resistance and ouTcomes

Penicillin allergy is one of the commonest reported allergies. The presence of a penicillin allergy record in a patients notes leads to the avoidance of recommended first-line penicillin antibiotics and the use of alternative non-penicillin antibiotics which can be less effective, have more side effects and have a greater propensity to drive antimicrobial resistance (AMR). Most patients with penicillin allergy records do not have a true allergy when they are tested by a specialist, so many patients are denied the best antibiotics because of an incorrect penicillin allergy record. The study will investigate how having a penicillin allergy impacts on treatment for patients who need antibiotics when they are hospitalised with COVID-19 and how penicillin allergy affects AMR. Antibiotic use is the main driver of AMR, antibiotic use can also disrupt the bacteria that normally live in our guts and mouths. These bacterial communities also known as the gastrointestinal (GI) and oral microbiome respectively, help us digest food and prevent infections. Antibiotic use can 'kill off' these harmless bacteria and lead to an increase in bacteria which have genes that make them resistant to antibiotics (antibiotic resistance genes). The study investigators believe that patients with penicillin allergy are likely to have a greater number of antibiotic resistance genes in their oral and GI microbiomes, ans that this will make it more likely that they will fail antibiotic treatment and will increase their risk of transmitting resistance to others. The study objectives are: 1. To determine how penicillin allergy impacts on clinical outcomes in patients admitted with COVID-19 2. To find out if AMR genes in the oral microbiome of people with a penicillin allergy record are different to those without a penicillin allergy record 3. To investigate whether AMR genes are lost in patients who have an incorrect penicillin allergy label removed

Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract

The aim of this research experiment is to evaluate the effectiveness of fecal microbiota transplantation (FMT) preceded by antibiotic pre-treatment versus probiotic therapy and a standard-of-care equivalent diet designed to stimulate the growth of eubiotic gut microbiota (an active comparator enhancing the ethical value of the study and increasing the chances of spontaneous decolonization of antibiotic-resistant bacteria (ARB) in the absence of any active intervention recommended by Scientific Societies) in the decolonization of bacteria with the most clinically significant antibiotic resistance mechanisms from the gastrointestinal tract of colonized patients. This study addresses the urgent need highlighted by the World Health Organization (WHO) for new strategies to combat antibiotic resistance, aiming to prevent its progression into a global pandemic that could undermine the achievements of modern civilization. Study Hypotheses: * The decolonization rate of ARB bacteria in patients undergoing the intervention (FMT or probiotic therapy) is the same as in patients treated with standard-of-care (SoC) alone. * The decolonization rate of ARB bacteria in the intervention groups (FMT or probiotic therapy) is at least 20 percentage points higher than in patients treated with the standard approach (diet). The findings from this study may contribute to developing innovative microbiota-based therapies for the decolonization of antibiotic-resistant bacteria and help reduce the global burden of antibiotic resistance.

The Predictive Value of Molecular Diagnostic Techniques in the Antimicrobial- Resistance Phenotypes of Pathogens

This observational study is to learn about the predictive value of targeted next-generation sequencing(tNGS) in pathogen resistance phenotype of patients with lower respiratory tract infection ,by detecting antimicrobial-resistant genes.

A Complex Intervention to Promote Appropriate Antibiotic Use Among Rural Residents Based on the Metaphor-Embedded Integrated Behavioral Model

The study aims to address the question of how to provide effective health education on health topics with high medical specialisation (e.g. bacterial drug resistance in this study), especially for rural or low-educated populations. In response to the high degree of correlation between irrational antimicrobial drug use behaviours, how to achieve the effectiveness of interventions on the complex health topic of rational use of antimicrobial drugs through synergistic interventions with multiple scenarios? In this study, the investigators used an experimental-like research design to conduct a full-scenario intervention involving antimicrobial drug acquisition, use, and disposal in a township-based approach, so as to reduce the prevalence of irrational antimicrobial drug use behaviours among rural residents, and to significantly improve the governance of antimicrobial drug use in rural areas. After six months of intervention, the following specific objectives were achieved: 1. The incidence of self-treatment and use of antimicrobial drugs in the intervention group decreased by 30% compared with the control group; 2. Rational use of antimicrobial drugs and awareness of bacterial drug resistance among rural residents in the intervention group increased by 50% compared with the control group; 3. In the intervention group, the incidence of rural residents actively asking for antimicrobial drugs when seeking medical treatment, actively purchasing antimicrobial drugs without prescription at community pharmacies, stocking up on antimicrobial drugs at home, and improperly disposing of antimicrobial drugs decreased by 40%, 30%, 30%, and 50%, respectively, compared with that of the control group. The study included the development and testing of metaphorical health materials and a multi-contextual metaphorical health education intervention. The implementation of the intervention included training in metaphorical health education and doctor-patient communication, a multi-situational intervention based on the theory of metaphorically embedded integrative behaviours, and the design of incentives for standardised antimicrobial drug discarding.

Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients

The goal of this observational study is to investigate how bacterial populations from the intestine and mouth of patients change during the hospitalization period and evaluate if some populations of specific bacteria increase or decrease the risk of acquiring an infection or becoming colonized by pathogenic bacteria. Participants will have the following samples collected during enrollment: stool samples (maximum 2x/week), blood draws (1x/week), oral swab (1x/week).