Leptospirosis Registry - LeptoScope

Recruiting

• Conditions: Leptospirosis
• Interventions: Other: Retrospective data collection of demographics; Other: Retrospective data collection of underlying diseases; Other: Retrospective data collection of duration of hospitalization

• Registration Number: NCT04288674
• Lead Sponsor: University of Cologne

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.

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Study Start: 2020-03-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2030-02
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Retrospective data collection of demographics	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)
Leptospirosis group	Retrospective data collection of demographics	Patients with cultural, serological, molecular or histological evidence and clinical evidence of invasive leptospirosis disease.
Leptospirosis group	Retrospective data collection of underlying diseases	Patients with cultural, serological, molecular or histological evidence and clinical evidence of invasive leptospirosis disease.
Leptospirosis group	Retrospective data collection of duration of hospitalization	Patients with cultural, serological, molecular or histological evidence and clinical evidence of invasive leptospirosis disease.
Control group	Retrospective data collection of underlying diseases	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)
Control group	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)

Primary Outcome Measures

Name	Time	Method
Mortality	up to 100 weeks	To describe global mortality due to invasive leptospirosis disease
Incidence	up to 100 weeks	To describe the global incidence of invasive leptospirosis disease

Secondary Outcome Measures

Name	Time	Method
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
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
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
Resistance development	up to 100 weeks	To describe resistance developments of Leptospirosis spp.
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
Need for renal replacement therapy	up to 500 weeks	To describe the need for renal replacement therapy approaches
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

Trial Locations

Locations (1)

University Hospital of Cologne; 🇩🇪 Cologne, Northrhine-Westphalia, Germany