Leptospirosis Registry - LeptoScope

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.

• Retrospective data collection of demographics (Other): Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.
• Retrospective data collection of underlying diseases (Other): Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.
• Retrospective data collection of duration of hospitalization (Other): Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.

Primary outcomes

• Incidence [up to 100 weeks]: To describe the global incidence of invasive leptospirosis disease
• Mortality [up to 100 weeks]: To describe global mortality due to invasive leptospirosis disease

Secondary outcomes

• Resistance development [up to 100 weeks]: To describe resistance developments of Leptospirosis spp.
• Treatment efficacy of invasive leptospirosis disease in participants with treatment failure [at 90 days from diagnosis]: To describe the number of participants with treatment failure
• Treatment efficacy of invasive leptospirosis disease in participants with stable disease [at 90 days from diagnosis]: To describe the number of participants with stable disease
• Treatment efficacy of invasive leptospirosis disease in participants with partial responses [at 90 days from diagnosis]: To describe the number of participants with partial responses
• Treatment efficacy of invasive leptospirosis disease in participants with complete responses [at 90 days from diagnosis]: To describe the number of participants with complete responses
• Occurrence of acute kidney injury according to KDIGO I, II, III [at 90 days from diagnosis]: To describe the occurrence of acute kidney injury according to KDIGO I, II, III disease
• Occurrence of chronic kidney disease [up to 500 weeks]: To describe the occurrence of chronic kidney disease
• Need for renal replacement therapy [up to 500 weeks]: To describe the need for renal replacement therapy approaches

Sex: All

Inclusion Criteria:

* 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).

Exclusion Criteria:

* Colonization or other non-invasive infection
* Cultural, serological, molecular or histological evidence without dissemination

• Volker Burst, MD, Study chair, University Hospital of Cologne
• Felix Köhler, MD, Principal investigator, University Hospital of Cologne