Leptospirosis Registry - LeptoScope

Leptospirosis Clinical Trial

— Leptoscope  

Official title:

Leptospirosis Registry - LeptoScope

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04288674
• Other study ID #: Version 1.0
• Status: Recruiting
• Start date: March 4, 2020
• Est. completion date: December 2030

Study information

• Verified date: May 2024
• Source: University of Cologne
• Contact: Felix Köhler, MD
• Phone: +4922147897222
• Email: felix.koehler[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2030
• Est. primary completion date: February 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Leptospirosis

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne	Northrhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence	To describe the global incidence of invasive leptospirosis disease	up to 100 weeks
Primary	Mortality	To describe global mortality due to invasive leptospirosis disease	up to 100 weeks
Secondary	Resistance development	To describe resistance developments of Leptospirosis spp.	up to 100 weeks
Secondary	Treatment efficacy of invasive leptospirosis disease in participants with treatment failure	To describe the number of participants with treatment failure	at 90 days from diagnosis
Secondary	Treatment efficacy of invasive leptospirosis disease in participants with stable disease	To describe the number of participants with stable disease	at 90 days from diagnosis
Secondary	Treatment efficacy of invasive leptospirosis disease in participants with partial responses	To describe the number of participants with partial responses	at 90 days from diagnosis
Secondary	Treatment efficacy of invasive leptospirosis disease in participants with complete responses	To describe the number of participants with complete responses	at 90 days from diagnosis
Secondary	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	at 90 days from diagnosis
Secondary	Occurrence of chronic kidney disease	To describe the occurrence of chronic kidney disease	up to 500 weeks
Secondary	Need for renal replacement therapy	To describe the need for renal replacement therapy approaches	up to 500 weeks

External Links

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