Loading clinical trials...
Loading clinical trials...
Showing 1-5 of 5 trials
NCT07379554
Transplants have improved clinical conditions for many patients with haematological diseases and end-stage organ diseases. However, immunosuppressive therapies that are necessary for avoiding organ rejection have a crucial impact in the occurrence of opportunistic infections. Despite the development of effective antimicrobial agents, infectious diseases are still related to mortality and morbidity in immunocompromised patients. Immune function assays can be adopted for monitoring T-cell function and eventually modify immunosuppression. Given the inverse relationship between cellular immune reconstitution and risk of infection, many transplant centers prospectively monitor immune recovery post-transplant. Some basic methods are useful, including white blood cells and T-lymphocyte subsets count. Given the complexity of immune responses required to resolve infections, functional assays are necessary and the only available FDA-approved one is Cyclex-Immuknow. Viral infections are common in patients with T-cell deficiencies and are of particular concern in those receiving high dose steroids. Opportunistic infections are common during the period of highest immunosuppression while community acquired infections, including fungal and respiratory viruses infections, have to be considered in the long-term period. Reduced CD4+ and CD8+ T-lymphocyte counts correlate with risk of opportunistic infection, including human cytomegalovirus (HCMV). Moreover, a decrease in human Rhinovirus (HRV) load in pediatric hematopoietic stem cell transplant recipients (HSCTRs) was associated with a significant increase in T-CD4+, T-CD8+ and NK lymphocytes, suggesting that cellular immunity have a crucial role in viral clearance and infectious control. A recent study showed that poor NK-cell cytotoxic activity is associated with increased risk for severe infections in kidney-graft recipients, suggesting that assessment of NK-cell function may be used as a predictor of infection in immunocompromised patients. Moreover, it has been recently reported that NKG2C genotype influences receptor function and NKG2C+ NK cell number in HCMV seropositive subjects. In detail, NKG2C genotype is significantly associated with HCMV viremia frequency and related disease after lung transplant and with symptomatic CMV infection after kidney transplant. Beside the use of non-specific immunological markers, the lack of standardized quantitative measures of protective immune functions specific for different opportunistic pathogens represents a challenge for clinicians. Overall, a comprehensive approach based on the use of combined non-specific and pathogen-specific immune assays may help in the definition of a composite immune risk profile of immunocompromised patients. The ultimate goal of this research is the definition of algorithms of infectious risk in immunocompromised patients, leading to a more adherent administration of immunosuppressive and antimicrobial therapies as well as to a personalized strategy of patients' management. Moreover, the design of new immunological assays that can be standardized and used in the clinical practice will be obtained. Currently, even if an immunological monitoring of immunocompromised patients is recommended, no standardized assays and protocols are available, especially for the use of antigen-specific or functional assays. The introduction of diagnostics algorithms will be useful for the stratification of patients at high risk of infections that will be monitored more frequently in order to prevent severe infections. Similarly, the administration of immunosuppressive drugs or ad hoc therapies might be tailored according to the risk of infections or complications. Objective is to identify a composite immune score measured either before or one month after transplant/chemotherapy able to define the risk for clinically significant infections (e.g. infections requiring antimicrobial therapy or hospitalization) during the following three months. Primary endpoint: To identify a composite immune score measured either before or one month after transplant/chemotherapy able to define the risk for clinically significant infections (e.g. infections requiring antimicrobial therapy or hospitalization) during the following three months. Secondary endpoints: * To evaluate the prognostic effect of the immunological score measured before or at first month after transplant/chemotherapy on the risk of severe infection during the following 6-12 months * To compare the role of the composite immunological score with specific assays against each pathogen. * To develop simple and rapid assays using whole blood to evaluate specific pathogen responses
NCT06683937
Due to the lower virulence of circulating Omicron variants and the high seroprevalence of anti-SARS-CoV-2 antibodies, the incidence of cases and deaths related to the SARS-CoV-2 virus has significantly decreased in recent months worldwide. However, these infections remain a major public health problem in severely immunocompromised patients, who have decreased vaccine efficacy and are at higher risk of persistent SARS-CoV-2 viral shedding, relapses, secondary invasive fungal infection, intensive care unit hospitalization, and death than non-immunocompromised patients. The research concerns adult patients at very high risk of severe SARS-CoV-2 disease, suffering from SARS-CoV-2 having resulted in hospitalization in a center participating in the study in France between June 1, 2023 and April 1, 2024 and having received mono- or dual therapy with nirmatrelvir/ritonavir or remdesivir in order to carry out an evaluation of direct antiviral treatments against SARS-CoV-2 in these immunocompromised patients suffering from Covid-19. The study consists of collecting patient care data from the medical record. Patients will be identified by practitioners at each participating French center.
NCT05597761
This multicenter, prospective, non-interventional study aims to evaluate data on humoral and cellular immune response generated within the COVID-19 vaccination standard in immunocompromised patients.
NCT05439044
Absence of anti-SARS-CoV-2 vaccine response or insufficient vaccine response may occur in immunocompromised patients. Being at high risk of a severe form of Covid-19, they may be eligible to receive recombinant anti-SARS-CoV-2 monoclonal antibodies (mAbs). This study aims to describe patients who received anti-SARS-CoV-2 mAbs, in prophylaxis and/or curative of covid-19, and to analyze the hospitalization and mortality rates. This study is multicentric on all the university hospitals of Paris (AP-HP).
NCT03597269
Pneumococcal infections are frequent and serious. Streptococcus pneumoniae is the leading cause of community-acquired pneumonia in adults. In metropolitan France, there are 6000 to 7000 bacteremic pneumococcal infections each year, with a mortality rate of 10 to 30% in adults. To fight against these bacterial infections, vaccines have been developed. At a time when antibiotic savings and the fight against antimicrobial resistance are major public health issues, vaccination is a first choice option to slow the development of pneumococcal resistance. Thus, after these different actions, the proportions of pneumococci with decreased susceptibility to penicillin G fell from 53 to 22%. While there is a significant decrease in invasive pneumococcal disease in children since the use of conjugate vaccines (vaccination of up to 94% of children), the rate of invasive Pneumococcal disease in adults has decreased less significantly. In March 2017, the High Council of Public Health (HCSP) proposed the vaccination of all non-immunocompromised adults at risk and immunocompromised patients. Awareness-raising among vaccinating physicians seems essential, especially in recent years when the value of vaccination is threatened by speculation about its efficacy and toxicity. However, the investigators know that vaccination aims not only to protect the individual, but also the population, especially children and the elderly and the fragile people. Thus, in the context of pneumococcal vaccination, identifying one or more profiles of patients at risk in the absence of vaccination could be particularly beneficial. Indeed, if the physician knows about the population at risk of not being vaccinated, it will be better able to identify patients at risk of not being protected against pneumococcus.