Actively Recruiting
Leptospirosis Registry - LeptoScope Observational Study of Invasive Leptospirosis Disease Worldwide
Led by University of Cologne · Updated on 2025-12-17
200
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Leptospirosis is a global zoonotic disease caused by harmful Leptospira bacteria. Humans become accidental hosts through exposure to animal urine, contaminated water or soil, or infected tissue. The disease can lead to serious conditions such as acute kidney injury, respiratory distress, heart inflammation, liver problems, bleeding, and multiple organ failure. Due to rising outbreaks and changing species distribution worldwide, there is an urgent need for global monitoring of its spread, clinical course, prognostic factors, and molecular characteristics. This research observes patients with invasive leptospirosis disease and matched controls from the same hospitals. It collects retrospective data on demographics, underlying diseases, and hospitalization duration to study the disease's epidemiology and clinical outcomes. The study aims to analyze mortality, incidence, treatment responses, resistance development, and kidney-related complications over periods up to several years, using a matched case-control design. Participants' medical records are reviewed for clinical evidence and laboratory confirmation of invasive leptospirosis. Researchers will assess outcomes such as disease incidence and mortality up to 100 weeks, treatment efficacy at 90 days, and kidney disease progression up to 500 weeks. The registry also monitors outbreaks and complications. The study does not involve investigational treatments but focuses on data collection and analysis to improve understanding of leptospirosis worldwide.
CONDITIONS
Brief Title
Leptospirosis Registry - LeptoScope
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cultural, serological, molecular or histological evidence of invasive leptospirosis disease
- Clinical signs of disseminated leptospirosis disease without laboratory evidence
- Control participants matched by demographics, underlying diseases, and hospitalization duration at the same hospitals as cases
You will not qualify if you...
- Colonization or other non-invasive leptospirosis infection
- Laboratory evidence of leptospirosis without dissemination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 100 weeks
Participants with invasive leptospirosis disease and matched controls are observed to collect data on epidemiology, clinical course, and outcomes.
Follow-up visits as per routine hospital care
Duration - Up to 500 weeks
Participants are monitored for long-term outcomes including chronic kidney disease and need for renal replacement therapy.
Periodic assessments depending on clinical course
Trial Site Locations
Total: 1 location
1
University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
Research Team
F
Felix Köhler, MD
F
Felix Köhler, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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