An observational study in Leptospirosis, sponsored by University of Cologne. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by University of Cologne · Observational
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.
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.
24 studies on the registry are indexed under Leptospirosis; 10 are open to participants now.
This study's planned enrollment of 200 is above the median of 175 across 11 observational studies indexed under Leptospirosis.
Browse Leptospirosis studies →University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Retrospective data collection from patients with cultural, serological, molecular or histological evidence of Leptospirosis spp. infection and clinical evidence of invasive leptospirosis disease (acute kidney injury, pulmonary manifestation with acute respiratory distress syndrome (ARDS), myocarditis with arrhythmia, hepatic dysfunction, hemorrhage, multi-organ failure).
Particularly, 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).
Exclusion Criteria:
Patients with cultural, serological, molecular or histological evidence and clinical evidence of invasive leptospirosis disease.
Other: Retrospective data collection of demographics · Other: Retrospective data collection of underlying diseases · Other: Retrospective data collection of duration of hospitalization
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)
Other: Retrospective data collection of demographics · Other: Retrospective data collection of underlying diseases · Other: Retrospective data collection of duration of hospitalization
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.
Incidence
To describe the global incidence of invasive leptospirosis disease
Time frame: up to 100 weeks
Mortality
To describe global mortality due to invasive leptospirosis disease
Time frame: up to 100 weeks
Resistance development
To describe resistance developments of Leptospirosis spp.
Time frame: up to 100 weeks
Treatment efficacy of invasive leptospirosis disease in participants with treatment failure
To describe the number of participants with treatment failure
Time frame: at 90 days from diagnosis
Treatment efficacy of invasive leptospirosis disease in participants with stable disease
To describe the number of participants with stable disease
Time frame: at 90 days from diagnosis
Treatment efficacy of invasive leptospirosis disease in participants with partial responses
To describe the number of participants with partial responses
Time frame: at 90 days from diagnosis
Treatment efficacy of invasive leptospirosis disease in participants with complete responses
To describe the number of participants with complete responses
Time frame: at 90 days from diagnosis
Occurrence of acute kidney injury according to KDIGO I, II, III
To describe the occurrence of acute kidney injury according to KDIGO I, II, III disease
Time frame: at 90 days from diagnosis
Occurrence of chronic kidney disease
To describe the occurrence of chronic kidney disease
Time frame: up to 500 weeks
Need for renal replacement therapy
To describe the need for renal replacement therapy approaches
Time frame: up to 500 weeks
Plan to share: No
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