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Leptospirosis Registry - LeptoScope

ConditionLeptospirosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Cologne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Colonization or other non-invasive infection

Cultural, serological, molecular or histological evidence without dissemination

Trial 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).

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Retrospective data collection of demographics

    Other intervention

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

  • Retrospective data collection of underlying diseases

    Other intervention

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

  • Retrospective data collection of duration of hospitalization

    Other intervention

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Leptospirosis group3 interventions
Group B: Control group3 interventions

Trial outcomes

Primary outcomes

1

Incidence

To describe the global incidence of invasive leptospirosis disease

Time frame
up to 100 weeks
2

Mortality

To describe global mortality due to invasive leptospirosis disease

Time frame
up to 100 weeks

Secondary outcomes

1

Resistance development

To describe resistance developments of Leptospirosis spp.

Time frame
up to 100 weeks
2

Treatment efficacy of invasive leptospirosis disease in participants with treatment failure

To describe the number of participants with treatment failure

Time frame
at 90 days from diagnosis
3

Treatment efficacy of invasive leptospirosis disease in participants with stable disease

To describe the number of participants with stable disease

Time frame
at 90 days from diagnosis
4

Treatment efficacy of invasive leptospirosis disease in participants with partial responses

To describe the number of participants with partial responses

Time frame
at 90 days from diagnosis

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cologne

Lead sponsor

Source ClinicalTrials.gov
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