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.
