LeptospirosisLeptoscopeNCT04288674
Leptospirosis Registry - LeptoScope
An observational study of Leptospirosis, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leptospirosis
- What is being tested?
- Retrospective data collection of demographics, Retrospective data collection of underlying diseases and Retrospective data collection of duration of hospitalization
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 4 Mar 2020to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- Colonization or other non-invasive infection
- Cultural, serological, molecular or histological evidence without dissemination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Felix Köhler, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
Felix Köhler, MD, felix.koehler@uk-koeln.de
Felix Köhler, MD, kidneyinfection@uk-koeln.de
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. 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.
Read the 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.
- Conditions
- Leptospirosis
- Being tested
- Retrospective data collection of demographics, Retrospective data collection of underlying diseases, Retrospective data collection of duration of hospitalization
- Medical subject headings
- Leptospirosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective data collection of demographicsOther
Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.
Retrospective data collection of underlying diseasesOther
Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.
Retrospective data collection of duration of hospitalizationOther
Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.
| Study group | Role | What they receive |
|---|---|---|
| Leptospirosis group | Patients with cultural, serological, molecular or histological evidence and clinical evidence of invasive leptospirosis disease. Receives: Other: Retrospective data collection of demographics; Other: Retrospective data collection of underlying diseases; Other: Retrospective data collection of duration of hospitalization | |
| 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) Receives: Other: Retrospective data collection of demographics; Other: Retrospective data collection of underlying diseases; Other: Retrospective data collection of duration of hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
To describe the global incidence of invasive leptospirosis disease
Measured: up to 100 weeks
Mortality
To describe global mortality due to invasive leptospirosis disease
Measured: up to 100 weeks
Secondary outcomes (8)
Resistance development
To describe resistance developments of Leptospirosis spp.
Measured: up to 100 weeks
Treatment efficacy of invasive leptospirosis disease in participants with treatment failure
To describe the number of participants with treatment failure
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 90 days from diagnosis
Occurrence of chronic kidney disease
To describe the occurrence of chronic kidney disease
Measured: up to 500 weeks
Need for renal replacement therapy
To describe the need for renal replacement therapy approaches
Measured: up to 500 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start4 Mar 2020
- Primary completionFeb 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeptospirosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, MD, Study chair, University Hospital of CologneFelix Köhler, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288674
- Sponsor's protocol ID
- Version 1.0
- Acronym
- Leptoscope
- Status last verified
- Dec 2025
- First submitted
- 12 Feb 2020
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leptospirosis Registry - LeptoScope
- ClinicalTrials.gov ID
- NCT04288674
- Acronym / sponsor ID
- Leptoscope / Version 1.0
- Conditions
- Leptospirosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leptospirosis group | – | Other: Retrospective data collection of demographics, Other: Retrospective data collection of underlying diseases, Other: Retrospective data collection of duration of hospitalizationPatients with cultural, serological, molecular or histological evidence and clinical evidence of invasive leptospirosis disease. |
| Control group | – | Other: Retrospective data collection of demographics, Other: Retrospective data collection of underlying diseases, Other: Retrospective data collection of duration of hospitalizationControls 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Colonization or other non-invasive infection
- Cultural, serological, molecular or histological evidence without dissemination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective data collection of demographicsRetrospective data collection of demographics from patients with leptospirosis and matching control group patients. | Other | Control group, Leptospirosis group |
| Retrospective data collection of underlying diseasesRetrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients. | Other | Control group, Leptospirosis group |
| Retrospective data collection of duration of hospitalizationRetrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients. | Other | Control group, Leptospirosis group |
Primary outcome
Incidence
Time frame: up to 100 weeks
To describe the global incidence of invasive leptospirosis disease
Mortality
Time frame: up to 100 weeks
To describe global mortality due to invasive leptospirosis disease
8 secondary outcomes
Resistance development
Time frame: up to 100 weeks
Treatment efficacy of invasive leptospirosis disease in participants with treatment failure
Time frame: at 90 days from diagnosis
Treatment efficacy of invasive leptospirosis disease in participants with stable disease
Time frame: at 90 days from diagnosis
Treatment efficacy of invasive leptospirosis disease in participants with partial responses
Time frame: at 90 days from diagnosis
Treatment efficacy of invasive leptospirosis disease in participants with complete responses
Time frame: at 90 days from diagnosis
Occurrence of acute kidney injury according to KDIGO I, II, III
Time frame: at 90 days from diagnosis
Occurrence of chronic kidney disease
Time frame: up to 500 weeks
Need for renal replacement therapy
Time frame: up to 500 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Related informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Leptospirosis
Not yet recruitingObservational study
Assessment of the Risk of Zoonotic Infections in Prisons in French Guiana
Q Fever, Leptospirosis
Not yet recruitingPhase 4
These Studies That Evaluated the Efficacy of Antibiotics for Leptospirosis Treatment.
Leptospirosis, Chemoprophylaxis
Recruiting
Leptospirosis Care Bundle Study
Leptospirosis
Active, not recruiting
Cohort of Hospitalized Patients Suspected of Leptospirosis
Leptospirosis
Not yet recruitingObservational study
Ex Vivo Study of Leukocyte Responses in the Blood of Patients With Leptospirosis and ex Vivo Testing of a New Host-targeted Therapeutic Strategy to Restore Phagocytosis of Leptospira
Leptospirosis, Jarisch Herxheimer Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Felix Köhler, MD contact
Volker Burst, MD study chair
University Hospital of Cologne
Felix Köhler, MD principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leptospirosis, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Köhler, MD (+4922147897222, felix.koehler@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: up to 100 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.