Lassa Fever Clinical Course and Prognostic Factors in Nigeria (LASCOPE)

July 18, 2023 updated by: Denis Malvy, Alliance for International Medical Action

Observational Cohort Study of Lassa Fever Clinical Course and Prognostic Factors in an Epidemic Context in Nigeria

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 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.

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Nigeria
    • Ebonyi
      • Abakaliki, Ebonyi, Nigeria
        • Recruiting
        • Alex Ekwueme Federal University Teaching Hospital Abakaliki
        • Contact:
    • Ondo
      • Owo, Ondo, Nigeria, PMB 1053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All the patients admitted in an isolation ward of one of the participating sites (tertiary hospitals) in Nigeria for a suspected or already RT-PCR confirmed diagnosis of Lassa fever during the study period are eligible to participate in LASCOPE.

The newborns from women infected by Lassa virus (RT-PCR confirmed) during their pregnancy are also eligible to participate, with the mother's agreement.

Description

Inclusion Criteria:

  • EITHER admission (inpatient) for suspected or already RT-PCR confirmed Lassa fever OR newborn from woman infected with Lassa virus during pregnancy
  • AND written informed consent of the patient or his/her legal representative (specific procedures for: immature minors, mature minors, incapable adults and unconscious adults; witnessed consent in case of illiteracy)

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Confirmed Lassa fever cases
Participants with a clinical presentation consistent with acute Lassa virus disease and a positive result for Lassa specific RT-PCR obtained before or after inclusion
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.
Non-Lassa cases (controls)
Participants with a clinical presentation consistent with acute Lassa virus disease but subsequently found to have a negative result for Lassa specific RT-PCR
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall mortality
Time Frame: 60 days after admission (day 60 after delivery for pregnant women and day 60 after birth for newborns from infected pregnant women).
Mortality rate among participants assessed at final visit.
60 days after admission (day 60 after delivery for pregnant women and day 60 after birth for newborns from infected pregnant women).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: Within 60 days after admission
Acute kidney injury or failure according to RIFLE criteria
Within 60 days after admission
Mother status at the end of pregnancy
Time Frame: Delivery
Is the mother dead or alive at the end of pregnancy
Delivery
Type of pregnancy termination
Time Frame: Delivery
Spontaneous delivery, induced delivery, cesarean section, medical interruption, miscarriage
Delivery
Pregnancy complications
Time Frame: Delivery
Reporting any type of pregnancy complications
Delivery
Newborn status at birth
Time Frame: Birth
Is the newborn dead or alive
Birth
Newborn status at day 30
Time Frame: Day 30 after birth
Is the newborn dead or alive
Day 30 after birth
Newborn status at day 60
Time Frame: Day 60 after birth
Is the newborn dead or alive
Day 60 after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for International Medical Action

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
University of Bordeaux
University of Oxford
University Hospital, Bordeaux
ANRS, Emerging Infectious Diseases
Bernhard Nocht Institute for Tropical Medicine
Institut de Recherche pour le Developpement
Irrua Specialist Teaching Hospital
PACCI Program
Owo Federal Medical Center
African coaLition for Epidemic Research, Response and Training

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2018

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD underlying results in scientific publications will be made available through the deposition of a datafile in a public data repository.

IPD Sharing Time Frame

Upon publication of related scientific works (undefined duration).

IPD Sharing Access Criteria

Free access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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