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NCT Number: NCT04034550

Cohort of Hospitalized Patients Suspected of Leptospirosis

COLEPT is a prospective interventional study that intends to better inform about leptospirosis, a neglected zoonotic infectious disease. During prospective follow-up of hospitalized acute leptospirosis cases, the participants will be assessed during 1 year for epidemiological, clinical, bacteriological and immunological data. Main intervention consists in blood sampling and biological bank constitution.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Leptospirosis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Spirochaetales Infections

Age range

1 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Est Réunion (GHER), Saint-Benoît, Reunion, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinico-biological manifestations compatible with acute leptospirosis OR proven leptospirosis with serological testing or PCR
  • onset of symptoms within 21 days
  • participant benefits of health insurance

Exclusion criteria

  • participant's refusal, or refusal from his relatives in case of major incapacity of the eligible participant precluding expression of his will (coma, stay in intensive care unit))

Treatment and study plan

Blood and urine sampling and blood banking

Other

In routine management, blood and urine will be sampled for each patients and specific analyses carried out. Only blood samples will be banked.

Primary outcomes

  1. disease severity

    Time frame: 0 to 21 days after onset of symptoms

    Rate of death or severe organ insuffisiency

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Acronym: COLEPT

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 26, 2019
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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