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Lassa Fever Clinical Course and Prognostic Factors in Nigeria

Study acronym: LASCOPE
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruitingv7 Show 4 more changesShow less
    • Primary completion date changed from estimate of Jun 30, 2024 to Apr 30, 2023
    • Study completion date: Jun 30, 2024 to Dec 31, 2025
    • Site details revised at 2 of 2 sites
    • Collaborators revised (11)
  2. Notable Primary and study completion dates: Jun 30, 2023 to Jun 30, 2024
    • Study sites: 1 to 2
    v6
  3. Minor Collaborators: 10 to 11v5
  4. Notable Primary and study completion dates: Jun 30, 2022 to Jun 30, 2023v4
  5. Minor Collaborators: 9 to 10v3
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The investigators propose to conduct a nationwide (Nigeria), prospective, non-interventional cohort study describing the clinical course, biological characteristics, case management and outcomes in patients hospitalized for a suspected or confirmed diagnosis of Lassa fever in tertiary medical facilities situated in the most affected Nigerian states. Special focuses will be made on situations at risk of bad outcome such as pregnancies, acute kidney injury and electrolytic imbalance in patients with confirmed Lassa fever. Participants for which the diagnosis of Lassa fever will be finally excluded by reverse-transcriptase polymerase chain reaction (RT-PCR) will constitute the control group.
Trial Details
NCT Number NCT03655561
Lead Sponsor Alliance for International Medical Action
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France, University of Oxford, Irrua Specialist Teaching Hospital, Bernhard Nocht Institute for Tropical Medicine, University Hospital, Bordeaux, University of Bordeaux, PACCI Program, Institut de Recherche pour le Developpement, ANRS, Emerging Infectious Diseases, Federal Medical Centre, Owo, European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions
(from sponsor)
Lassa Fever, Lassa Virus Infection, Pregnancy Complications, Acute Kidney Injury, Acute Kidney Failure, Coma
Related terms Acute Kidney Injury, Coma, Lassa Fever, Pregnancy Complications
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov