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Prevalence and Incidence of Lassa Virus Infection in Southern Mali

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ClinicalTrials.gov Identifier: NCT03783143
Recruitment Status : Not yet recruiting
First Posted : December 20, 2018
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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.


Condition or disease
Lassa Virus Infection

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. Participants will be asked to give blood samples at baseline and annually for 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. 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. Individual participation for both studies will last through a common end date, up to 4 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.


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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serosurvey for Prevalence and Incidence of Lassa Virus Infection in Southern Mali
Estimated Study Start Date : December 11, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Group/Cohort
Clinical Cohort
This study population will consist of patient volunteers that visit one of our clinical sites withan undiagnosed febrile illness.
Cross-sectional Cohort
Cross sectional study participants are volunteers from the general population selected from census lists.



Primary Outcome Measures :
  1. Determine the prevalence and annual incidence of seoconversion to LASV infection in the general population around each study site in the LASV endemic area of southern Mali. [ Time Frame: At time of study start ]
    Determine the prevalence and annual incidence of seroconversion to LASV infection in the general population around each study site in the LASV-endemic area of southern Mali

  2. Determine the incidence of LF in febrile patients attending health centers in southern Mali [ Time Frame: Over 3 years ]
    Determine the incidence of LF in febrile patients attending health centers in southern Mali over 3 years.


Secondary Outcome Measures :
  1. Determine the biological, clinical, and virologic parameters of LASV-Soromba infection in study participants with LF. [ Time Frame: At time of study start. ]
    Determine the biological, clinical, and virologic parameters of LASV-Soromba infection in study participants with LF.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria
  • INCLUSION CRITERIA:

    1. Age greater than or equal to 6 months to 99 years.
    2. Resident of one of the study administrative districts, or moved to the area at least 3 months ago.
    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 C), 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 malaria (negative or 1+ in thick smear) 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 bronchopneumonia, 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783143


Contacts
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Contact: Heinrich U Feldmann, M.D. (406) 375-7410 feldmannh@mail.nih.gov

Locations
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Mali
Icer/Mrtc/Fmos/Usttb Not yet recruiting
Bamako, Mali
Contact: Seydou Doumbia    76461339    sdoumbi@icermail.org   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Heinrich U Feldmann, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03783143     History of Changes
Other Study ID Numbers: 999919029
19-I-N029
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 3, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Febrile
Human
Lassa Fever
Seroconversion
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Lassa Fever
Virus Diseases
Arenaviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral