Lassa Fever Clinical Course and Prognostic Factors in Nigeria

NCT03655561 | Active Not Recruiting

• 1 other identifier: LAS001
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Lassa fever; Lassa virus; Nigeria; Pregnancy; Acute kidney injury

Outcome Measures

Primary Outcomes (1)

• Overall mortality

  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 Outcomes (7)

• Acute kidney injury

  Within 60 days after admission

• Mother status at the end of pregnancy

  Delivery

• Type of pregnancy termination

  Delivery

• Pregnancy complications

  Delivery

• Newborn status at birth

  Birth

Study Arms (2)

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

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

Interventions

Non interventional research OTHER

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.

Confirmed Lassa fever cases; Non-Lassa cases (controls)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Alliance for International Medical Action: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• University of Oxford: collaborator
• Irrua Specialist Teaching Hospital: collaborator
• Bernhard Nocht Institute for Tropical Medicine: collaborator
• University Hospital, Bordeaux: collaborator
• University of Bordeaux: collaborator
• PACCI Program: collaborator
• Institut de Recherche pour le Developpement: collaborator
• ANRS, Emerging Infectious Diseases: collaborator
• Federal Medical Centre, Owo: collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (2)

Alex Ekwueme Federal University Teaching Hospital Abakaliki

Abakaliki, Ebonyi State, Nigeria

Location

Owo Federal Medical Centre (Owo FMC)

Owo, Ondo State, PMB 1053, Nigeria

Location

Related Publications (1)

• Duvignaud A, Jaspard M, Etafo IC, Serra B, Abejegah C, Gabillard D, Doutchi M, Alabi JF, Adedokun MA, Akinpelu AO, Oyegunle OO, Etafo J, Dede AO, Onyechi MN, Ireneh MU, Gbenga-Ayeni O, Fadiminiyi KG, Ehigbor PI, Ouattara E, Levy-Marchal C, Karcher S, N'guessan-Koffi L, Ahyi I, Amani E, Diabate M, Siloue B, Schaeffer J, Augier A, Ogbaini-Emovon E, Salam AP, Horby P, Ahmed LA, Gunther S, Adedosu AN, Anglaret X, Ayodeji OO, Malvy D. Lassa fever clinical course and setting a standard of care for future randomized trials: A protocol for a cohort study of Lassa-infected patients in Nigeria (LASCOPE). Travel Med Infect Dis. 2020 Jul-Aug;36:101557. doi: 10.1016/j.tmaid.2020.101557. Epub 2020 Jan 21.

  PMID: 31978611 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Leftover blood, urine, milk and any other bodily fluid samples. Option for genetic analyses regarding immunity against infectious diseases.

MeSH Terms

Conditions

Lassa Fever; Pregnancy Complications; Acute Kidney Injury; Coma

Condition Hierarchy (Ancestors)

Arenaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Denis Malvy, MD, PhD

  Inserm 1219 - Infectious Diseases in Ressource Limited Countries

  PRINCIPAL INVESTIGATOR

• Oladele O Ayodeji, MD

  Owo Federal Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Infectious Diseases and Tropical Medicine

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: August 31, 2018
• Study Start: April 5, 2018
• Primary Completion: April 30, 2023
• Study Completion: December 31, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon publication of related scientific works (undefined duration).
• Access Criteria: Free access.

Locations

NG (2)