Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Kidney Failure
  • Acute Kidney Injury
  • Coma
  • Lassa Fever
  • Lassa Virus Infection
  • Pregnancy Complications
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

The LASCOPE project refers to a nationwide, prospective, non-interventional cohort study describing the clinical course, biological characteristics, case management and outcomes in patients hospitalized for a suspected or already RT-PCR confirmed diagnosis of Lassa fever in tertiary medical faciliti...

The LASCOPE project refers to a nationwide, prospective, non-interventional cohort study describing the clinical course, biological characteristics, case management and outcomes in patients hospitalized for a suspected or already RT-PCR confirmed diagnosis of Lassa fever in tertiary medical facilities situated in the most affected Nigerian states. The project will start during the 2018 Lassa fever season and is intended to be extended to at least three sites throughout Nigeria on a 3 years period. The investigators will try to depict the pathophysiological mechanisms underlying the conditions associated to a fatal outcome in patients with RT-PCR confirmed Lassa fever, with a special focus on pregnancies, acute renal injury and electrolytic imbalance. Population and setting - Participants will be recruited in tertiary reference hospitals for Lassa fever case management in the Nigerian States identified to have the highest burden, including Owo Federal Medical Center (OFMC), Owo, Ondo State as a pilot site (list to be completed according to the outbreak dynamics). Inclusion criteria - All the patients hospitalized for suspected or already RT-PCR confirmed Lassa fever will be eligible (no age restriction). Newborns from mothers participating in the study will also be eligible. Sample size - Given the descriptive purpose of the study, there is no pre-determined sample size. Follow-up - After informed consent collection, data concerning the patient's life habits, contacts, disease history, clinical and biological status, management and outcome will be collected anonymously upon admission and throughout the hospital stay. The follow-up will end 60 days after admission (60 days after delivery for pregnant women and 60 days after birth for newborns) with a phone call or a home visit (or an outpatient visit at hospital if needed). Leftover biological samples, if any, will be stored for further analysis with the participant's agreement. The biobank will be registered once constituted and further use of stored samples will be subject to material transfer agreements.

Tracking Information

NCT #
NCT03655561
Collaborators
  • Institut National de la Santé Et de la Recherche Médicale, France
  • University of Oxford
  • Owo Federal Medical Center
  • Irrua Specialist Teaching Hospital
  • Bernhard Nocht Institute for Tropical Medicine
  • University Hospital, Bordeaux
  • University of Bordeaux
  • PACCI Program
  • African coaLition for Epidemic Research, Response and Training
  • Institut de Recherche pour le Developpement
Investigators
Principal Investigator: Denis Malvy, MD, PhD Inserm 1219 - Infectious Diseases in Ressource Limited Countries Principal Investigator: Oladele O Ayodeji, MD Owo Federal Medical Centre