Идёт набор NCT04288674

Leptospirosis Registry - LeptoScope

— Наблюдательное Leptospirosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Retrospective data collection of demographics, Retrospective data collection of underlying diseases, Retrospective data collection of duration of hospitalization.
Кому может быть актуально: Состояния в реестре: Leptospirosis. Базовые параметры: Без ограничений · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

Leptospirosis is a worldwide zoonotic diseases caused by pathogenic Leptospira spp. Human are accidental hosts, who acquired infections after exposition to animal urine, contaminated water or soil, infected tissue. Incidence of invasive leptospirosis disease causing acute kidney injury, acute respiratory distress syndrome (ARDS), myocarditis, hepatic dysfunction, hemorrhage and multi-organ failure, is globally increasing and there have been frequent outbreak situation throughout the world. Due to increasing outbreak situations and globally chances in species distributions, a worldwide surveillance in epidemiology and species distribution is urgently needed. The objective of the Leptospirosis Registry - LeptoScope is to overcome the lack knowledge on epidemiology, clinical course, prognostic factors and molecular characteristics for invasive leptospirosis disease.

Подробное описание

Leptospirosis is a worldwide zoonotic diseases caused by pathogenic Leptospira spp. Human are accidental hosts, who acquired infections after exposition to animal urine, contaminated water or soil, infected tissue. During bacteremia, Leptospira spp. may lead to invasive, deep-seated leptospirosis with infection of kidney, liver, heart and the central nervous system. Although cleaned from blood and most tissue by immune response, Leptospira spp. can persists and multiply in the tubuli of kidneys.

Incidence of invasive leptospirosis disease causing acute kidney injury, acute respiratory distress syndrome (ARDS), myocarditis, hepatic dysfunction, hemorrhage and multi-organ failure, is globally increasing and there have been frequent outbreak situation throughout the world. In Europe, invasive leptospirosis disease is less common than in the tropical and subtropical countries, however due to climate change incidence is rising, and there are worry-some trends concerning chancing species distribution and multiple outbreak situations throughout central Europe. Current treatment approaches consist of antibiotic therapies. Additionally, salvage supportive treatment approaches of critical ill patients are common in invasive leptospirosis disease requiring dialysis, hemodynamic support, mechanical ventilation or even extracorporeal membrane oxygenation (ECMO). Furthermore, invasive leptospirosis disease is associated with the development of chronic kidney disease.

Due to increasing outbreak situations and globally chances in species distributions, a worldwide surveillance in epidemiology and species distribution is urgently needed. Additionally, the examination of attributable mortality and costs analysis of invasive leptospirosis disease will need to be studied on a multinational basis and therefore LeptoScope will particularly use a matched case control design.

The objective of the Leptospirosis Registry - LeptoScope is to overcome the lack knowledge on epidemiology, clinical course, prognostic factors and molecular characteristics for invasive leptospirosis disease. Additionally, LeptoScope serves as a platform for monitoring complications of invasive leptospirosis disease and outbreak situations.

Вмешательства

Другое Retrospective data collection of demographics
Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.
Другое Retrospective data collection of underlying diseases
Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.
Другое Retrospective data collection of duration of hospitalization
Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.

Первичные конечные точки

Incidence [Срок оценки: up to 100 weeks]
Mortality [Срок оценки: up to 100 weeks]

Вторичные конечные точки (8)

Resistance development [Срок оценки: up to 100 weeks]
Treatment efficacy of invasive leptospirosis disease in participants with treatment failure [Срок оценки: at 90 days from diagnosis]
Treatment efficacy of invasive leptospirosis disease in participants with stable disease [Срок оценки: at 90 days from diagnosis]
Treatment efficacy of invasive leptospirosis disease in participants with partial responses [Срок оценки: at 90 days from diagnosis]
Treatment efficacy of invasive leptospirosis disease in participants with complete responses [Срок оценки: at 90 days from diagnosis]
Occurrence of acute kidney injury according to KDIGO I, II, III [Срок оценки: at 90 days from diagnosis]
Occurrence of chronic kidney disease [Срок оценки: up to 500 weeks]
Need for renal replacement therapy [Срок оценки: up to 500 weeks]

Критерии участия

Критерии включения

Cultural, serological, molecular or histological evidence of invasive leptospirosis diseases
Clinical signs of disseminated leptospirosis disease without cultural, serological, molecular or histological evidence
Case controls: Matching procedures for controls: Particularly, case controls will be included at the same hospitals that conduced cases based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital).