Clinical trial NCT03655561: Lassa Fever Clinical Course and Prognostic Factors in Nigeria
Official title: Observational Cohort Study of Lassa Fever Clinical Course and Prognostic Factors in an Epidemic Context in Nigeria
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Alliance for International Medical Action
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: University of Oxford
name: Irrua Specialist Teaching Hospital
name: Bernhard Nocht Institute for Tropical Medicine
name: University Hospital, Bordeaux
name: University of Bordeaux
name: PACCI Program
name: Institut de Recherche pour le Developpement
name: ANRS, Emerging Infectious Diseases
name: Federal Medical Centre, Owo
name: European and Developing Countries Clinical Trials Partnership (EDCTP)
First posted: 2018-08-31
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall mortality
timeFrame: 60 days after admission (day 60 after delivery for pregnant women and day 60 after birth for newborns from infected pregnant women).
Secondary outcomes:
measure: Acute kidney injury
timeFrame: Within 60 days after admission
measure: Mother status at the end of pregnancy
timeFrame: Delivery
measure: Type of pregnancy termination
timeFrame: Delivery
measure: Pregnancy complications
timeFrame: Delivery
measure: Newborn status at birth
timeFrame: Birth
measure: Newborn status at day 30
timeFrame: Day 30 after birth
measure: Newborn status at day 60
timeFrame: Day 60 after birth
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: Alex Ekwueme Federal University Teaching Hospital Abakaliki
state: Ebonyi
city: Owo
country: Nigeria
facility: Owo Federal Medical Centre (Owo FMC)
state: Ondo
Study officials:
affiliation: Inserm 1219 - Infectious Diseases in Ressource Limited Countries
name: Denis Malvy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Owo Federal Medical Centre
name: Oladele O Ayodeji, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.