Език: EN EN
← Назад към резултатите
Набира участници NCT06418048

INfectious DIsease REgistry BIObank

Заболявания: Bloodstream Infections Central Nervous System Infections Bone and Joint Infections Endovascular Infections Infective Endocarditis CIED-related Infections Vertebral Osteomyelitis

Спонсор: IRCCS San Raffaele

Налично на: БГ
Обобщение
Prospective observational study designed to describe the clinical, laboratory, imaging, microbiological characteristics and treatment of specific infectious diseases, with the addition of a dedicated biobank.
Описание
The registry would provide a comprehensive database including a vast population of patients with infectious diseases, favoring the analysis of clinical, laboratory and therapeutic data of specific infectious conditions. Specific infectious diseases of major interest include, among others: * Bloodstream infections (i.e.: infectious syndromes manifesting with bacteremia) * Endovascular infections (i.e.: infective endocarditis, cardiovascular implantable electronic device infections, vascular graft infections, etc.) * Central nervous system infections (i.e.: meningitis, encephalitis, cerebral abscess, ventricular shunts infections, etc.) * Bone and joint infections (i.e.: osteomyelitis, spondylodiscitis, prosthetic joint infections, etc.) * Sexually transmitted infections (i.e.: gonococcal and non-gonococcal urethritis, proctitis, epididymo-orchitis, syphilis, etc.) * HIV infection * Emerging and re-emerging infectious diseases. General objectives of the study for each specific infectious disease include: * description and evolution over time of clinical and laboratory characteristics of patients with specific infectious diseases; * description and evolution over time of microbial isolates, including antimicrobial susceptibility testing; * description and evolution over time of treatment employed in patients with specific infectious diseases; * evaluation of predictive factors for treatment success and mortality in patients with specific infectious diseases; * description, evaluation and prognostic impact of microbial, immunological and inflammatory biomarkers. The general study objectives, along with more specific objectives related to a specific infectious disease, will be evaluated in specific observational studies, nested within the Registry (i.e., using data and biosamples collected in the Registry with the potential addition of data obtained from investigations performed on available biological samples). To achieve these objectives, participants are asked to donate biological samples (blood, cerebrospinal fluid, urine, other relevant biological samples related to the specific infectious disease, collected according to good clinical practice and available guidelines) for studies to identify modifiers of a specific infectious disease and to establish and validate biological markers tracking the progressive course of the considered disease, along with drug efficacy and toxicity. The following clinical and laboratory data will be recorded at baseline and at follow-up visits: * Age, measured in years * Sex at birth (male, female) * Comorbidities, measured with Charlson score (minimum 0 - maximum 37; higher scores linked to worse outcome) * Source of infection, (central nervous system, respiratory tract, endovascular infection, intra-abdominal, urinary tract, skin and soft tissue, bone and joint, other). * Sequential Organ Failure Assessment (SOFA) score (minimum 0 - maximum 24; higher scores linked to worse outcome) * Pitt Score (minum 0 -
Кой може да участва
Inclusion Criteria: * Patients with clinically suspected or microbiologically documented infectious diseases (bacterial, viral, fungal or parasitic); * At least 18 years of age or older; * Able to provide informed consent; * Participants who are unable to understand the study protocol or are unable to give informed consent, but have a legal representative Exclusion Criteria: \- Participants who are unable to understand the study protocol or are unable to give informed consent, and have no legal representative.
Места на провеждане 1
Италия (1)
San Raffaele Scientific Institute
Milan
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.02.2024
Крайна дата
31.07.2044
Регистрационен номер
NCT06418048
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.