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NCT Number: NCT04288674

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location status: Recruiting

Location contact

Felix Köhler, MD

CONTACT

[email protected]

Felix Köhler, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Incidence

    Time frame: up to 100 weeks

    To describe the global incidence of invasive leptospirosis disease

  2. Mortality

    Time frame: up to 100 weeks

    To describe global mortality due to invasive leptospirosis disease

Secondary outcomes

  1. Resistance development

    Time frame: up to 100 weeks

    To describe resistance developments of Leptospirosis spp.

  2. Treatment efficacy of invasive leptospirosis disease in participants with treatment failure

    Time frame: at 90 days from diagnosis

    To describe the number of participants with treatment failure

  3. Treatment efficacy of invasive leptospirosis disease in participants with stable disease

    Time frame: at 90 days from diagnosis

    To describe the number of participants with stable disease

  4. Treatment efficacy of invasive leptospirosis disease in participants with partial responses

    Time frame: at 90 days from diagnosis

    To describe the number of participants with partial responses

  5. Treatment efficacy of invasive leptospirosis disease in participants with complete responses

    Time frame: at 90 days from diagnosis

    To describe the number of participants with complete responses

  6. Occurrence of acute kidney injury according to KDIGO I, II, III

    Time frame: at 90 days from diagnosis

    To describe the occurrence of acute kidney injury according to KDIGO I, II, III disease

  7. Occurrence of chronic kidney disease

    Time frame: up to 500 weeks

    To describe the occurrence of chronic kidney disease

  8. Need for renal replacement therapy

    Time frame: up to 500 weeks

    To describe the need for renal replacement therapy approaches

Study contacts

Contact information is provided by the study sponsor or research team.

Felix Köhler, MD

CONTACT

[email protected]

+4922147897222

Felix Köhler, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Acronym: Leptoscope

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Feb 28, 2020
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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