Leptospirosis Registry Gathers Knowledge on Epidemiology, Clinical Course, Prognostic Factors and Molecular Characteristics for Invasive Leptospirosis Disease (Leptoscope)

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. 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.

Study Overview

• Status: Recruiting
• Conditions: Leptospirosis
• Intervention / Treatment: Other: Retrospective data collection of demographics; Other: Retrospective data collection of underlying diseases; Other: Retrospective data collection of duration of hospitalization

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Felix Köhler, MD; Phone Number: +4922147897222; Email: felix.koehler@uk-koeln.de
• Study Contact Backup: Name: Felix Köhler, MD; Email: kidneyinfection@uk-koeln.de

Study Locations

• Germany
  • Northrhine-Westphalia
    • Cologne, Northrhine-Westphalia, Germany, 50937
      • Recruiting
      • University Hospital of Cologne
      • Contact: Felix Köhler, MD; Email: felix.koehler@uk-koeln.de
      • Contact: Felix Köhler, MD; Email: kidneyinfection@uk-koeln.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; 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; Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.; Other: Retrospective data collection of underlying diseases; Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.; Other: Retrospective data collection of duration of hospitalization; Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.
Leptospirosis group; Patients with cultural, serological, molecular or histological evidence and clinical evidence of invasive leptospirosis disease.	Other: Retrospective data collection of demographics; Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.; Other: Retrospective data collection of underlying diseases; Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.; Other: Retrospective data collection of duration of hospitalization; Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence	To describe the global incidence of invasive leptospirosis disease	up to 100 weeks
Mortality	To describe global mortality due to invasive leptospirosis disease	up to 100 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resistance development	To describe resistance developments of Leptospirosis spp.	up to 100 weeks
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
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
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
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
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
Occurrence of chronic kidney disease	To describe the occurrence of chronic kidney disease	up to 500 weeks
Need for renal replacement therapy	To describe the need for renal replacement therapy approaches	up to 500 weeks

Collaborators and Investigators

• Sponsor: University of Cologne

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2020
• Primary Completion (Anticipated): February 1, 2030
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Spirochaetales Infections; Leptospirosis; Weil Disease
• Other Study ID Numbers: Version 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No