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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03655561
Other study ID # LAS001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 5, 2018
Est. completion date June 30, 2024

Study information

Verified date July 2023
Source Alliance for International Medical Action
Contact Alexandre Duvignaud, MD, PhD
Phone +33557822220
Email alex.duvignaud@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Nigeria Alex Ekwueme Federal University Teaching Hospital Abakaliki Abakaliki Ebonyi
Nigeria Owo Federal Medical Centre (Owo FMC) Owo Ondo

Sponsors (12)

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

Country where clinical trial is conducted

Nigeria, 

Outcome

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