Design and Set-up of the Leptospirosis Registry LeptoScope for Epidemiology, Outbreaks and Clinical Studies on Human Leptospirosis

Sadrija Cukoski¹Thomas Theo Brehm^2,3,4Stefan Büttner⁵Jens Van Praet⁶Sebastian Dolff⁷Lukas Eberwein⁸Iker Falces Romero⁹Oliver A. Cornely^10,11,12Manuel Wanken¹Roman-Ulrich Mueller^1,12,13Volker Burst^1,14Felix Carlo Koehler^1,12,15*

• ¹Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany
• ²Division of Infectious Diseases, I. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
• ³German Centre for Infection Research (DZIF), Partner Site Hamburg-Lübeck-Borstel-Riems, Hamburg, Germany
• ⁴Department of Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center, Borstel, Germany
• ⁵Medical Clinic III, Cardiology, Pneumology, Nephrology and Intensive Care Medicine, Klinikum Aschaffenburg-Alzenau, Aschaffenburg, Germany
• ⁶Department of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge AV, Brugge, Belgium
• ⁷Department of Infectious Diseases, West German Center of Infectious Diseases, Essen University Hospital, University of Duisburg-Essen, Essen, Germany
• ⁸Department III of Internal Medicine, Städtisches Klinikum Solingen, Solingen, Germany
• ⁹Microbiology and Parasitology Department, Hospital Universitario La Paz, IdiPAZ, CIBERINFEC, Madrid, Spain
• ¹⁰Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany
• ¹¹Clinical Trials Centre Cologne (ZKS Köln), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany
• ¹²Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany
• ¹³Center for Rare Diseases Cologne, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany
• ¹⁴Emergency Department, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany
• ¹⁵Department of Internal Medicine (Nephrology) & Einthoven Laboratory of Vascular and Regenerative Medicine, Leiden University Medical Center, Leiden, Netherlands

Objective: Human leptospirosis is a widespread, waterborne zoonosis with endemic appearance in different parts of the world. Despite causing more than 1 million cases, nearly 60.000 deaths and 3 million disability-adjusted life-years per year, leptospirosis remains an underrecognized and neglected disease calling for multinational surveillance and international collaboration. Methods: The leptospirosis registry LeptoScope is a novel project enabling both international and multi-disciplinary research on Leptospira-caused diseases. LeptoScope has an electronic case report form and can be assessed on the General Data Protection Regulation compliant platform clinicalsurveys.net. Due to its modular structure, LeptoScope depicts or hides items according to the documented case (e.g. patients treated in outpatient setting versus patient admitted to the intensive care unit). This ensures rapid, but standardized enrolment of patients even in epidemics. Results: Information collected in LeptoScope include demographics, pre-existing diseases, clinical presentation and measures in addition to outcome. A multinational research team from Germany, Belgium and Spain contributed a pilot cohort of 78 cases with Leptospira-associated diseases to confirm LeptoScope's functionality and practicality. Conclusion: LeptoScope is to our knowledge the first worldwide research platform on public health and clinical studies concerning Leptospira-associated diseases. LeptoScope promotes the needed collaboration at the cross-roads of public health, microbiology, infectious diseases and nephrology for an underrecognized and often neglected disease. Ensuring controlled or uncontrolled level II evidence LeptoScope may improve patient care and may provide evidence for robust treatment recommendations in future.