Lassa Fever Clinical Course and Prognostic Factors in Nigeria

Active, not recruiting

• Conditions: Pregnancy Complications; Acute Kidney Failure; Lassa Fever; Lassa Virus Infection; Acute Kidney Injury; Coma
• Interventions: Other: Non interventional research

• Registration Number: NCT03655561
• Lead Sponsor: Alliance for International Medical Action

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.

Study Timeline

• Study Start: 2018-04-05
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-30
• Study First Posted: 2018-08-31
• Primary Completion: 2023-04-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Confirmed Lassa fever cases	Non interventional research	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
Non-Lassa cases (controls)	Non interventional research	Participants with a clinical presentation consistent with acute Lassa virus disease but subsequently found to have a negative result for Lassa specific RT-PCR

Primary Outcome Measures

Name	Time	Method
Overall mortality	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Owo Federal Medical Centre (Owo FMC); 🇳🇬 Owo, Ondo, Nigeria

Alex Ekwueme Federal University Teaching Hospital Abakaliki; 🇳🇬 Abakaliki, Ebonyi, Nigeria