Lassa Fever Clinical Course and Prognostic Factors in Nigeria

NCT03655561 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2025-01-29

No results posted yet for this study

Summary

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.

Conditions

  • Lassa Fever
  • Lassa Virus Infection
  • Pregnancy Complications
  • Acute Kidney Injury
  • Acute Kidney Failure
  • Coma

Interventions

OTHER

Non interventional research

Participants are receiving the standard of care according to Nigerian Center for Disease Control (NCDC) Standard Operating Procedures for Lassa fever case management. This include the administration of intravenous ribavirin for Lassa confirmed cases as well as critically-ill Lassa suspected cases.

Sponsors & Collaborators

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

    collaborator OTHER_GOV
  • University of Oxford

    collaborator OTHER
  • Irrua Specialist Teaching Hospital

    collaborator OTHER
  • Bernhard Nocht Institute for Tropical Medicine

    collaborator OTHER_GOV
  • University Hospital, Bordeaux

    collaborator OTHER
  • University of Bordeaux

    collaborator OTHER
  • PACCI Program

    collaborator OTHER
  • Institut de Recherche pour le Developpement

    collaborator OTHER_GOV
  • ANRS, Emerging Infectious Diseases

    collaborator OTHER_GOV
  • Federal Medical Centre, Owo

    collaborator INDUSTRY
  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV
  • Alliance for International Medical Action

    lead OTHER

Principal Investigators

  • Denis Malvy, MD, PhD · Inserm 1219 - Infectious Diseases in Ressource Limited Countries

  • Oladele O Ayodeji, MD · Owo Federal Medical Centre

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2023-04-30
Completion
2025-12-31

Countries

  • Nigeria

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03655561 on ClinicalTrials.gov