Clinical trial NCT04288674: Leptospirosis Registry - LeptoScope
Official title: Leptospirosis Registry - LeptoScope
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leptospirosis
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence
timeFrame: up to 100 weeks
measure: Mortality
timeFrame: up to 100 weeks
Secondary outcomes:
measure: Resistance development
timeFrame: up to 100 weeks
measure: Treatment efficacy of invasive leptospirosis disease in participants with treatment failure
timeFrame: at 90 days from diagnosis
measure: Treatment efficacy of invasive leptospirosis disease in participants with stable disease
timeFrame: at 90 days from diagnosis
measure: Treatment efficacy of invasive leptospirosis disease in participants with partial responses
timeFrame: at 90 days from diagnosis
measure: Treatment efficacy of invasive leptospirosis disease in participants with complete responses
timeFrame: at 90 days from diagnosis
measure: Occurrence of acute kidney injury according to KDIGO I, II, III
timeFrame: at 90 days from diagnosis
measure: Occurrence of chronic kidney disease
timeFrame: up to 500 weeks
measure: Need for renal replacement therapy
timeFrame: up to 500 weeks
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: Northrhine-Westphalia
Study officials:
affiliation: University Hospital of Cologne
name: Volker Burst, MD
role: STUDY_CHAIR
affiliation: University Hospital of Cologne
name: Felix Köhler, MD
role: PRINCIPAL_INVESTIGATOR
References: