Clinical trial NCT03783143: Prevalence and Incidence of Lassa Virus Infection in Southern Mali
Official title: Serosurvey for Prevalence and Incidence of Lassa Virus Infection in Southern Mali
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lassa Virus Infection
Keywords: Febrile
Human
Lassa Fever
Seroconversion
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2018-12-20
Enrollment: 8524
Sex: ALL
Minimum age (years): 6
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals will be randomly identified from village census lists, and a member of the study team will contact the individual by phone or in person about potential participation in the study. In accordance with cultural practices, the individual s entire household will be invited to participate

Brief summary: Background:

The disease Lassa fever mostly affects people in Western Africa. It is very similar to other diseases that cause fever, like malaria and yellow fever. People get Lassa fever from mice infected with Lassa virus. It can also be spread from body fluids of people with the disease. Researchers want to learn more about this virus in Mali so they can develop better tools to diagnose and prevent it.

Objective:

To find out how many people in certain areas of southern Mali have ever had Lassa fever and count how many people get the disease every year.

Eligibility:

People ages 6 months to 99 years who live in certain areas of Mali

Design:

Women who are could become pregnant will have a urine pregnancy test at each visit.

Participants will be asked questions about their age, if they have ever had a fever, and if they have ever seen mice in or around their home. This will take about 20 minutes.

Participants will give a blood sample using a needle in a vein in the arm. Young children will give it by pricking a finger or heel with a needle.

Patients with a fever illness will have a medical history and physical exam. They will give blood and nasal swabs 3 times over 21 days.

Participants may be asked to come back 1 time each year for up to 3 more years to take another sample of blood and answer more questions.

Detailed description: In West Africa, as many as 300,000 people are infected annually with Lassa virus (LASV), resulting in approximately 5,000 deaths. Most commonly, human infection comes from contact with infected rodent hosts (Mastomys natalensis), or ingestion or inhalation of virus-laden particles. Person-to-person transmission is also well documented and can cause outbreaks, especially in nosocomial settings. Infection in pregnancy, especially the third trimester, is particularly severe, with maternal mortality rates estimated at 20% and fetal mortality rates nearing 100%. A survey of rodents captured in the village of Soromba (rural commune of Sibirila, district of Bougouni, Mali) found that 25% of M. natalensis had evidence of LASV infection. A 2015 study of LASV infection in the human populations of this region showed seroprevalence of 33.2% and annual incidence rate of 6.3% in 2016.

The purpose of this serosurvey study is to determine the prevalence and incidence of human exposure to LASV in the administrative districts of Bougouni, Yanfolila, and Kolondieba in southern Mali. The study involves 2 separate sub-studies. Study 1 is a cross-sectional serosurvey of residents of the general population selected from a census. The study will follow up to 500 participants at each of 4 study sites (Fakola, Bamba, Filamana, and Guelelinkoro). Participants will be asked to give blood samples at baseline and annually for up to 3 years. Study 2 is a clinic-based serosurvey conducted at local health centers following up to 500 participants per year at each of the 4 study sites (Fakola, Bamba, Filamana, and Guelelinkoro). Patients who report with febrile illness suggestive of Lassa fever will be asked to give blood and nasal swab samples, then return for follow-up visits 5 and 21 days later for clinical consultation and additional blood and swab collection.

All participants will be provided with free medical treatment according to local standard of care as needed for the duration of the study. They will be followed passively between study visits and instructed to report to their local health center if they have a fever. Study visits will be conducted through a common end date, up to 3 years.

Blood and nasal swab samples will be used to identify history of or current LASV infection and for exploratory studies into the biochemistry and pathophysiology of LASV infection. Elucidating the prevalence of LASV infection in the populations of southern Mali may help Malian authorities improve surveillance, and additional research may help develop diagnostics and treatment.

Eligibility criteria: * INCLUSION CRITERIA:

  1. Age greater than or equal to 6 months to 99 years.
  2. Resident of one of the study sites for at least 3 months.
  3. Able to provide informed consent.
  4. Agrees to allow storage of samples for future research.

Additional inclusion criteria for the cross-sectional study (study 1):

1. No plans to relocate before the study end date.

Additional inclusion criteria for the clinic-based study (study 2):

1. Has fever (temperature greater than or equal to 38 degree celcius), or has had antecedent of fever for at least 2 consecutive days at the time of screening.
2. One or more of the following:

   1. Excluded typhoid fever and and has at least 1 of the following symptoms: chest pain, sore throat, headache, muscle pain,vomiting, and diarrhea.
   2. Shows bleeding or facial edema.
   3. Does not respond to anti-malarials or antibiotics after 2 days of treatment.
   4. Had contact with a confirmed LF case within the last 3 weeks.

EXCLUSION CRITERIA:

General exclusion criteria:

1. Any condition that, in the opinion of the investigator, contraindicates participation in this study, including conditions that could hinder compliance or that could place participants or study staff at increased risk.
2. Pregnancy.

Additional exclusion criteria for the clinic-based study (study 2):

1. Signs or symptoms of fever-associated conditions other than LF, such as urinary tract infection, or any other infection that may cause fever.

Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment

Primary outcomes:
measure: Determine the prevalence and
timeFrame: At time of study start
measure: Determine the incidence of LF in febrile patients attending health centers in southern Mali
timeFrame: Over 3 years
Secondary outcomes:
measure: Determine the biological, clinical, and virologic parameters of LASV-Soromba infection in study participants with LF.
timeFrame: At time of study start.
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: Icer/Mrtc/Fmos/Usttb
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Heinrich U Feldmann, M.D.
role: PRINCIPAL_INVESTIGATOR
References: