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Leptospirosis Registry - LeptoScope

Leptospirosis Registry - LeptoScope

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04288674
Acronym
Leptoscope
Enrollment
200
Registered
2020-02-28
Start date
2020-03-04
Completion date
2030-12-31
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leptospirosis

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.

Interventions

OTHERRetrospective data collection of demographics

Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.

OTHERRetrospective data collection of underlying diseases

Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.

OTHERRetrospective data collection of duration of hospitalization

Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidenceup to 100 weeksTo describe the global incidence of invasive leptospirosis disease
Mortalityup to 100 weeksTo describe global mortality due to invasive leptospirosis disease

Secondary

MeasureTime frameDescription
Treatment efficacy of invasive leptospirosis disease in participants with stable diseaseat 90 days from diagnosisTo describe the number of participants with stable disease
Treatment efficacy of invasive leptospirosis disease in participants with partial responsesat 90 days from diagnosisTo describe the number of participants with partial responses
Treatment efficacy of invasive leptospirosis disease in participants with complete responsesat 90 days from diagnosisTo describe the number of participants with complete responses
Resistance developmentup to 100 weeksTo describe resistance developments of Leptospirosis spp.
Occurrence of chronic kidney diseaseup to 500 weeksTo describe the occurrence of chronic kidney disease
Need for renal replacement therapyup to 500 weeksTo describe the need for renal replacement therapy approaches
Occurrence of acute kidney injury according to KDIGO I, II, IIIat 90 days from diagnosisTo describe the occurrence of acute kidney injury according to KDIGO I, II, III disease
Treatment efficacy of invasive leptospirosis disease in participants with treatment failureat 90 days from diagnosisTo describe the number of participants with treatment failure

Countries

Germany

Contacts

Primary ContactFelix Köhler, MD
felix.koehler@uk-koeln.de+4922147897222
Backup ContactFelix Köhler, MD
kidneyinfection@uk-koeln.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026