Clinical Research Directory

A Digital Escape Room to Teach Medical Students About Antimicrobial Resistance Using the One Health Approach

The goal of this clinical trial is to evaluate the effectiveness of a One Health-based educational intervention in final-year medical students from two universities in Norway and Zambia. The main question it aims to answer is: 1. Does AMRageddon improve total AMR knowledge scores, particularly in clinical case reasoning, compared with traditional lectures? 2. Does AMRageddon enhance students' awareness of AMR and One Health principles more effectively than lectures? Researchers will compare students who receive AMRageddon (intervention arm) with students who receive lecture-based teaching (control arm) to see if the gamified approach leads to greater improvements in knowledge, awareness, and behaviour. Participants will: 1. Attend either a gamified interactive session (AMRageddon) or a standard lecture-based session on AMR. 2. Complete a baseline questionnaire assessing AMR knowledge, awareness, and behaviour. 3. Complete a follow-up questionnaire one month after the educational session to evaluate changes in outcomes.

A Digital Escape Room to Teach Veterinary Students About Antimicrobial Resistance Using the One Health Approach

The goal of this study is to evaluate the effectiveness of a One Health-based educational intervention in second-year medical students from the veterinary university in Norway The main question it aims to answer is: 1. Does AMRageddon improve total AMR knowledge scores, particularly in clinical case reasoning, compared with traditional lectures? 2. Does AMRageddon enhance students' awareness of AMR and One Health principles more effectively than lectures? Researchers will compare students who receive AMRageddon (intervention arm) with students who receive lecture-based teaching (control arm) to see if the gamified approach leads to greater improvements in knowledge, awareness, and behaviour. Participants will: 1. Attend either a gamified interactive session (AMRageddon) or a standard lecture-based session on AMR. 2. Complete a baseline questionnaire assessing AMR knowledge, awareness, and behaviour. 3. Complete a follow-up questionnaire after after the educational session to evaluate changes in outcomes.

Implementation of a Sepsis Chart and Its Effects on Mortality Rate in Indonesian Primary Referral Hospitals

The goal of this observational study is to evaluate the effectiveness of implementing Koran Sepsis, or sepsis chart, a paper-based order set designed to guide the implementation of the One-hour Sepsis Bundle, in improving adherence to early sepsis management and reducing 7-day mortality among adult patients with sepsis presenting to the Emergency Department. The main questions it aims to answer are: 1. Does implementation of a sepsis chart improve adherence to the One-hour Sepsis Bundle among adult patients with sepsis? 2. Does implementation of a sepsis chart reduce 7-day mortality among adult patients with sepsis? Researchers will compare the period before and after implementation of Koran Sepsis to determine whether its implementation improves adherence to the One-hour Sepsis Bundle and reduces 7-day mortality. Participants will: * Receive standard clinical care for sepsis, with management documented during the first hour after sepsis is suspected or diagnosed. * Receive care guided by sepsis chart after its implementation at the participating hospital. * Have clinical data collected from their medical records, including adherence to the One-hour Sepsis Bundle and time to administration of broad-spectrum antibiotics. * Be followed for seven days to determine their mortality outcome. The study will include adult patients aged ≥18 years diagnosed with sepsis according to the Sepsis-3 definition who present to the Emergency Department and are admitted to one of two participating hospitals: Cipto Mangunkusumo and Fatmawati General Hospital.

Molecular-based Optimization of Pathogen Identification in Sepsis Patients in the Indonesian National Referral Hospital

This study aims to compare the diagnostic performance of conventional blood culture with two molecular-based diagnostic approaches, Hybrispot DNA Flow and metagenomic next-generation sequencing (mNGS), for the identification of microorganisms in patients with sepsis. The study will evaluate the turnaround time of each diagnostic method and assess their potential impact on the time to definitive antimicrobial therapy and subsequent clinical outcomes. The study is led by Robert Sinto, an infectious disease physician at Dr. Cipto Mangunkusumo National Referral Hospital (RSCM), the national referral hospital in Indonesia. Conventional blood culture, which serves as the standard microbiological diagnostic method, may require about 5 to 7 days to obtain a final result. In comparison, Hybrispot DNA Flow and mNGS detect microbial genetic material and may provide microbiological results within approximately 2 to 3 days. By comparing these diagnostic strategies, the study seeks to determine whether molecular-based approaches can facilitate more rapid pathogen identification and support earlier optimization of antimicrobial therapy. Participation in the study is voluntary. Participants may withdraw from the study at any time without affecting the medical care they receive. Participants may also request information about their diagnostic results and may ask the research team to clarify any aspect of the study that they do not understand.

One Health Determinants of Rectal Colonization by ESBL-Producing Enterobacterales in the Community

This multicenter cross-sectional observational study aims to determine the prevalence of rectal colonization by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales among community-dwelling adults in Argentina and to identify biological, clinical, sociocultural, occupational, and environmental factors associated with colonization. Participants will be recruited from sentinel healthcare centers and will undergo collection of rectal swabs, fecal samples, urine samples, and standardized epidemiological questionnaires. The study is based on a One Health framework and will evaluate potential determinants of antimicrobial resistance, including previous healthcare exposure, antibiotic use, animal contact, occupational exposures, environmental conditions, water access, dietary habits, and pesticide exposure. Biological samples will be stored in an institutional biobank for future molecular, microbiome, resistome, and toxicological analyses. Findings are expected to improve understanding of community-associated antimicrobial resistance and support the development of preventive public health strategies.

Prevalence of Multidrug-Resistant Organism Infections in General Adult Wards in Argentina (PREV-AR 2 - IGA)

This study measures how common infections caused by multidrug-resistant organisms (MDROs) are among adult patients hospitalized in general medical and surgical wards in Argentina, and how these infections relate to in-hospital death. Background: A 2019 national survey (ENPIHA 2019), conducted across 255 hospital units in Argentina, found that nearly 29% of hospitalized patients had a healthcare-associated infection, most often caused by Klebsiella pneumoniae, Acinetobacter species, Pseudomonas aeruginosa, E. coli, and Staphylococcus aureus. Most prior regional studies combined data from intensive care and general ward patients together, making it hard to know how much of this burden specifically affects general medical/surgical wards. This study is designed to answer that question directly. On a single day chosen by each hospital between August 4 and 6, 2026, doctors and infection-control staff at participating hospitals across Argentina will record information about every adult patient (18 years or older) who has been in a general adult ward for at least 24 hours. For each patient, the study team records basic demographics, underlying health conditions, whether the patient has an active infection that day, the site and type of that infection, the organism responsible, whether that organism is drug-resistant, and what antibiotics are being used. No study procedures, tests, or treatments are performed - the study only records information that is already part of routine hospital care. Each patient is then followed for up to 60 days after the study day, using existing hospital records, to determine whether they were discharged alive or died in the hospital. No patient names or other identifying information are collected; each patient is assigned a code known only to the local site investigator. This study is sponsored by the Sociedad Argentina de Infectología (SADI), in collaboration with the Sociedad Argentina de Terapia Intensiva (SATI) and the Sociedad Argentina de Medicina (SAM), with no external funding. It is one component of a larger multi-part project, PREV-AR 2, which separately surveys neonatal intensive care units and adult intensive care units at other points in 2026. This registration covers only the general adult ward (Internación General de Adultos, IGA) component.

Correlation Between Carbapenemase-Producing Enterobacterales Load, Environmental Contamination, and Transmission in Critical Care Units

Carbapenemase-producing Enterobacterales (CPE) are multidrug-resistant bacteria that can colonize the gastrointestinal tract of hospitalized patients and spread within intensive care units (ICUs). Some colonized individuals may carry a particularly high bacterial burden and contribute disproportionately to environmental contamination and transmission to other patients. Identifying these high-risk individuals could improve infection prevention and control strategies. This prospective observational study will be conducted in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires. Patients identified as colonized with CPE through routine surveillance will undergo quantitative culture and real-time polymerase chain reaction (PCR) testing of rectal swabs to measure bacterial load. Environmental samples will also be collected from high-touch surfaces surrounding colonized patients. In selected cases, molecular typing methods will be used to evaluate genetic relatedness between patient and environmental isolates and to investigate possible transmission events. The primary objective is to determine the correlation between bacterial load measured by culture and the PCR cycle threshold (Ct) value. Secondary objectives include evaluating the association between bacterial load and environmental contamination, and assessing whether patients with higher bacterial loads are more likely to contribute to transmission within the ICU. Results may help identify patients with increased dissemination potential and support targeted infection prevention interventions.

PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE

A multicenter international prospective observational pharmacological study in adult patients (≥18 years) treated with ceftazidime/avibactam (CAZ/AVI) alone or with CAZ/AVI plus fosfomycin (FOS) for infection due to carbapenem-resistant Enterobacterales (CRE) (KPC and/or OXA-48).

Salivary Microbiota and Antimicrobial Resistance in Relation to Chlorhexidine Use

This study evaluated the ecological effects of 0.06% chlorhexidine toothpaste on the salivary microbiota of healthy individuals, focusing on taxonomic composition, functional shifts, and prevalence of predicted antimicrobial resistance genes. Saliva samples were collected from eleven healthy participants at three specific time points: baseline (following a 4-week run-in period using a control toothpaste), intervention (after 12 weeks of using 0.06% chlorhexidine digluconate toothpaste), and washout (after a subsequent 12-week period using the control toothpaste). Sequencing targeted the 16S rRNA V3-V4 region.

Development and Implementation of Mobile Antibiograms to Optimize Empirical Antibiotic Prescriptions Among Prescribers in Tertiary Hospitals in Tanzania

Antimicrobial resistance (AMR) is a critical issue, especially in Africa, with resistance to common antibiotics reaching 100% in some areas. In Tanzania, limited access to culture tests and antibiograms forces healthcare providers to rely on experience for prescribing, heightening AMR risks. This study aims to determine the effectiveness of mobile antibiograms in optimizing empirical antibiotic therapy in tertiary hospitals in Tanzania.

NCCR AntiResist:: New Approaches to Combat Antibiotic-resistant Bacteria

This is an explorative, mono-center study including prospectively collected patient samples from the University Hospital of Basel. It is to investigate antimicrobial resistance (AMR) including three clinical manifestations of infectious diseases: urinary tract infection, pneumonia and deep-seated infections. The focus is on four bacteria (E. coli, Klebsiella species, S. aureus, P. aeruginosa) that are part of the high priority list of World Health Organization (WHO). Residual patient samples are analysed for proteomic, metabolomic and transcriptomic analysis, immunocytochemical or fluorescence in-situ hybridisation (FISH) analysis, flow cytometry analysis (FACS) and immunophenotyping and exploration of bacterial properties.

PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections

A multicenter, national, prospective, observational pharmacological study of patients with difficult-to-treat Gram-negative infections treated with ceftazidime/avibactam (CAZ/AVI) or cefiderocol (CEF) monotherapy or combination therapy with ceftazidime/avibactam associated with fosfomycin (FOS) or cefiderocol associated with fosfomycin.