Clinical Research Directory

Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV

We are studying virologic and/or immunologic parameters of HIV infection and other infectious or non-infectious immune deficiency diseases in order to better understand the pathogenesis of HIV. Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood cells for studying aspects of either in vivo or in vitro HIV infection. We wish to be able to continue to elucidate many pathogenic aspects of HIV infection in relation to other infectious or non-infectious immune regulation and dysregulation using human peripheral blood mononuclear cells as a model.

Prescription Support System for Antimicrobial Use in Belgian Primary Care

Inappropriate antibiotic prescribing in primary care remains an important contributor to antimicrobial resistance. Despite the availability of evidence-based clinical guidelines, antibiotics are still frequently prescribed for self-limiting infections. Digital clinical decision support tools may help general practitioners (GPs) align prescribing decisions with guideline recommendations during patient consultations. This study evaluates the impact of a digital Prescription Support System (PSS) designed to support antimicrobial prescribing in Belgian primary care. The PSS provides guideline-based recommendations derived from the Belgian BAPCOC guidelines for common infections in ambulatory care. Recommendations are presented through a user-friendly decision tree that is integrated into existing electronic health record systems and can be consulted during routine care. The study is embedded within the national implementation strategy of the PSS coordinated by the National Institute for Health and Disability Insurance (RIZIV-INAMI). A stepped-wedge cluster randomized design is used, in which participating general practices transition sequentially from usual care to access to the PSS over four predefined implementation steps. This approach ensures that all participating practices eventually receive access to the system while allowing comparisons over time. The primary objective is to assess whether implementation of the PSS is associated with changes in antibiotic prescribing in Belgian general practice. Prescribing outcomes are measured using routinely collected indicators from the Belgian Antibiotic Barometer, including overall antibiotic prescribing rates and the use of broad- versus narrow-spectrum antibiotics. Secondary objectives include assessing the usability and acceptability of the PSS among clinicians and identifying factors that influence its adoption in daily practice. The study will also monitor potential unintended consequences, such as changes in workflow or concerns about underprescribing. Findings from this study will inform future decisions regarding further optimization and wider implementation of the PSS in Belgian primary care.

Fostering Prosocial Preventive Behaviours Through Awe

The goal of this randomized control trial is to investigate the impact pf awe on prosocial preventive behaviours against infectious diseases among adults from Hong Kong, Singapore, and ten major cities in Mainland China (Beijing, Shanghai, Guangzhou, Shenzhen, Hangzhou, Chongqing, Chengdu, Wuhan, Xi'an, Nanjing). The main questions it aims to answer are: * Does experiencing awe increase adults' intentions to engage in prosocial preventive behaviours against infectious diseases, including vaccination, mask wearing, and social distancing? * Does the impact vary across three research sites?

Rapamycin and Infection-related Illness

Conduct a 6-month observational pilot clinical trial to evaluate the safety, monitor the adverse reactions and observe the preliminary effectiveness of medical treatment with oral rapamycin \[Rapamune (Sirolimus)\] in a total of 15 adults, 18 years and older toward preventing and lowering the severity of infectious disease or infection-related illness. Rapamune (Sirolimus) is not approved by the United States Food and Drug Administration (FDA) to prevent and lessen the severity of infection-related illness or infectious disease. Rapamune (Sirolimus) is approved by the FDA for other indications. The main procedures in the study include: * Blood tests to examine cholesterol, lipids, blood platelet counts, inflammation and infection-related health parameters * Questionnaires to examine brain function, mental health, symptoms, overall health status and quality of life * Electrocardiogram (ECG to measure heart function) * Resting diastolic and systolic blood pressure

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.

A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan

The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan. Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate. This study is seeking for patients with: * sepsis (A very serious infection in your blood caused by germ (a bacteria)) or * renal impairment (loss of kidney function) who are administrated with Zavicefta for the first time. Subjects will take part in this study from the start date of receiving Zavicefta (Day 1) to Day 28.

Real-world Multicentre Study of AZtreonam-AVIbactam Treatment With Infections or Suspected Infections Caused by Multidrug-resistant Gram-negative Bacteria

The AZAVI study is a multicenter observational registry (ICU and Infectious Diseases departments), designed to evaluate the real-world use of aztreonam-avibactam for suspected or documented infections caused by metallo-β-lactamase (MBL)-producing Enterobacterales or highly resistant Gram-negative bacteria. The study combines a retrospective cohort (patients treated during the 12 months prior to the drug's hospital availability) and a prospective cohort (patients consecutively included over 24 months). The primary outcome is clinical success at day 7 after antibiotic discontinuation, defined as resolution of signs and symptoms of infection without recurrence or need for additional active therapy. Secondary outcomes include microbiological eradication, 14-day and 28-day all-cause mortality, infection relapse, length of stay, safety outcomes, and predictors of treatment failure. Data will be collected using a standardized CRF, including demographics, severity scores, infection site and pathogens, therapeutic regimens, organ failures and support, adverse events, and outcomes. Descriptive statistics and multivariable models will be used to assess real-world effectiveness, identify determinants of clinical response, and inform stewardship strategies. This registry will provide the first national-scale evidence on the role of aztreonam-avibactam in critically ill patients outside the framework of controlled clinical trials.

Impaired Type I IFN Immunity Due to Autoantibodies or a Genetic Defect: a Prospective National Cohort

The major role of human genetic factors in the immune response to infections is now well established, particularly for viral infections. In the context of the COVID-19 pandemic, the following results have identified 1) several inborn errors of immunity (IEI) affecting the response or production of type I interferons (type I IFNs) in around 4% of adult patients with severe clinical disease, and 2) the presence of type I IFN-neutralizing autoantibodies (auto-Abs) in around 15% of severe cases, and 20% of deaths. The investigators would like to carry out a longitudinal immunological and clinical follow-up study on a prospective cohort of patients with either a genetic defect affecting the type I IFN-dependent immune response, or anti-IFN-I auto-Abs, to monitor the incidence of infectious and/or autoimmune events in these individuals, the evolution of neutralizing power, and the kinetics of auto-Abs. This should lead to a better understanding of the prevention and management of these patients. The research design is a national multicenter prospective cohort of adults with 1) anti-IFN-I auto-Abs or 2) IEI- IFN-I, with follow-up from 1 to 4 years. These individuals may be: 1) patients who have or have had clinical disease (related to COVID-19, other viral infections, autoimmune disorders); or 2) "healthy" participants (e.g. blood donors, relatives of an IEI patient). Follow-up will include: * yearly visits to the Clinical Investigation Center (CIC) or a clinical department with blood sampling; * specific visit in case of hospitalization for infectious events or adverse effects of vaccination, exacerbation or new diagnosis of auto-immune disease, new diagnosis of cancer, or SARS-CoV-2 infection whether or not patients are admitted to hospital, with blood sampling. In addition, a retrospective "passive" follow-up will be implemented through matching with the data from the SNDS (National Health Data System), in order to collect clinical events of and healthcare resource consumption. Moreover, matching with controls adults from the national CONSTANCES cohort, not carrying auto-Abs against type I IFNs nor IEI-IFN-I, will be performed. (ratio 3:1; matching on age (+/- 5 years), gender and geographic region of recruitment). Individuals under long-lasting immunosuppressive or immunomodulatory drugs will not be eligible. Follow-up of controls, which will be carried out as part of the CONSTANCES cohort, will include web-based questionnaires, every 12 months, in addition to linking with SNDS data as already done in this cohort. Inclusion visit: After signing the consent form, the following tests will be performed: * Demographic characteristics (sex, age, country of birth) * Medical history from participant and family member(s) including infectious and auto-immune diseases, cancers and vaccination status and side effects * Blood samples for: * full blood cell count; * classical autoimmune investigations (anti-nuclear, anti-ENA, native anti-DNA, anti- thyroid antibodies, rheumatoid factor); * immunophenotyping\*; * auto-Abs against type I IFNs, other cytokines\*, or other target proteins\* (dosage and neutralization activity); * Genetic explorations by whole-exome or whole-genome sequencing\*; * Biobanking (DNA, plasma/sera; cryopreserved peripheral blood mononuclear cells (PBMCs). * these biological analyses will be carried out as part of dedicated COVIFERON RHU5 workpackages. In addition, vaccination against SARS-CoV-2 and influenza will be offered to these subjects as a priority, as part of their usual care. Follow-up visits : Annual visits to the CIC : * Medical history since last visit, including infectious, auto-immune and oncologic events, vaccination status and side effects * Blood samples for: * full blood cell count; * classical autoimmune investigation (anti-nuclear, anti-ENA, native anti- DNA, anti-thyroid antibodies, rheumatoid factor); * immunophenotyping; * Auto-Abs against type I IFNs, other cytokines, or other target proteins (dosage and neutralization) * Biobanking (DNA, plasma, cryopreserved peripheral blood mononuclear cells (PBMCs)) Additional specific visit in the event of a clinical event of interest, at any time during follow-up: * In case of SARS-CoV-2 infection, whatever the severity of the disease: blood sampling for determination and neutralization of type I anti-IFN autoAbs, CBC, and biobanking (plasma and PBMC) and teleconsultation with the CIC in charge of patients, as soon as possible. * In the event of hospitalization for infectious events or exacerbation or new diagnosis of an auto-immune disease: blood sampling for determination and neutralization of anti-IFN-I autoAbs, CBC, and biobanking (plasma and PBMCs) and collection of the hospitalization report in the case report form on a dedicated page.

Omaha System-Based Health Application on Improving Knowledge, Attitude, and Behaviors Regarding Infectious Disease Prevention in the Community

Background: Infectious diseases remain significant public health concerns due to several factors such as climate and environmental changes and natural disasters. Mobile health applications (mHealth apps) can be an appropriate way for fostering community participation, disseminating knowledge, and promoting behavior change toward infectious disease prevention. This study aims to describe a protocol for a pilot randomized controlled study to evaluate the impact of the Omaha System-Based mHealth app (BUHOS) on improving knowledge, attitude, and behaviors (KAB) regarding infectious disease prevention in an earthquake-affected region of Türkiye. Methods: This study is a two-armed, parallel-group, randomized controlled trial design. A total of 112 eligible participants will be recruited from two separate container cities of an earthquake-affected region. These participants will be randomly allocated to either an intervention group or a control group. BUHOS will be designed based on the Omaha System, a widely recognized standardized taxonomy for the assessment, planning, and evaluation of healthcare services. BUHOS will be a two-week nursing intervention that includes monitoring KAB, employing Education, Guidance and Counseling (education videos), and Surveillance (reminder messages), and assessing the outcomes. Outcome variables will include the Problem Rating Scale for Outcomes, Community Communicable Diseases Knowledge Survey, Communicable Diseases Risk Awareness and Protection Scale and System Usability Scale. Outcome variables will be assessed on the 15th and 30th day after intervention. Hypotheses: H1: Among the Omaha System Problems, the Communicable/ Infectious Condition Problem Knowledge score will be higher on the 15th and 30th days compared to the control group. H2: Infectious diseases risk awareness and prevention score will be higher on the 15th and 30th days compared to the control group. H3: Communicable/ Infectious Condition Status Behaviour Parameter score will be higher on the 15th and 30th days compared to the control group H4: The knowledge and behaviour of the communicable/ infectious status and the awareness and prevention of the risk of infectious diseases of the experimental group will be higher than before the intervention on the 15th and 30th days.

A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine

The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles). Subjects will be randomized to receive either JCXH-105 or Shingrix.

Biobank of Samples From Patients With Infectious Diseases

The aim of the INFECTIOTEK biobank will be to prospectively build a biobank of multiple biological samples from patients with infectious diseases in order to identify diagnostic and prognostic biomarkers, genetic susceptibility factors and immune response mechanisms in such diseases. The population of the study will consist of patients treated in the Infectious Diseases Departments of Saint-Louis and Lariboisière Hospitals, with a diagnosis of infectious disease, and who have biological samples in the context of their routine medical care. The diseases studied in this research project are bacterial infections (urinary tract infections, neurologic infections, sexually transmitted infections, pulmonary infections), viral infections (HIV, hepatitis, respiratory viruses, viruses affecting immunocompromised patients) and fungal infections (Aspergillus, Mucorales, Cryptococcus). These diseases are the domains of expertise and research of the clinical and biological teams at the Saint-Louis and Lariboisière hospitals.

Key Technology Research and Application Demonstration of Individual Protective Equipment for High-Level Biosafety Laboratories

Systematically evaluate the safety performance, intelligent application effect and experience of PPE developed in different scenarios.

LoewenKIDS - Infections and the Development of the Immune System

The purpose of this study is to determine in what way infections, microbiome, and vaccinations during childhood interact in shaping the development of immunity and tolerance. The investigators collect and use data from a birth cohort focusing on infectious diseases during childhood and apply a life course perspective.

LMP1 CAR-T for Patients With LMP1 Positive Infectious Diseases and Hematological Malignancies

A study of LMP1 CAR-T for patients with LMP1 positive infectious diseases and hematological malignancies