University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937, Germany
Location status: Recruiting
NCT Number: NCT04288674
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.
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Observational
Cologne, North Rhine-Westphalia, 50937, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.
Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.
Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.
Time frame: up to 100 weeks
To describe the global incidence of invasive leptospirosis disease
Time frame: up to 100 weeks
To describe global mortality due to invasive leptospirosis disease
Time frame: up to 100 weeks
To describe resistance developments of Leptospirosis spp.
Time frame: at 90 days from diagnosis
To describe the number of participants with treatment failure
Time frame: at 90 days from diagnosis
To describe the number of participants with stable disease
Time frame: at 90 days from diagnosis
To describe the number of participants with partial responses
Time frame: at 90 days from diagnosis
To describe the number of participants with complete responses
Time frame: at 90 days from diagnosis
To describe the occurrence of acute kidney injury according to KDIGO I, II, III disease
Time frame: up to 500 weeks
To describe the occurrence of chronic kidney disease
Time frame: up to 500 weeks
To describe the need for renal replacement therapy approaches
Contact information is provided by the study sponsor or research team.
Felix Köhler, MD
CONTACT
Felix Köhler, MD
CONTACT
University of Cologne
Other
Acronym: Leptoscope
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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