<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03783143</url>
  </required_header>
  <id_info>
    <org_study_id>999919029</org_study_id>
    <secondary_id>19-I-N029</secondary_id>
    <nct_id>NCT03783143</nct_id>
  </id_info>
  <brief_title>Prevalence and Incidence of Lassa Virus Infection in Southern Mali</brief_title>
  <official_title>Serosurvey for Prevalence and Incidence of Lassa Virus Infection in Southern Mali</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      The disease Lassa fever mostly affects people in Western Africa. It is very similar to other&#xD;
      diseases that cause fever, like malaria and yellow fever. People get Lassa fever from mice&#xD;
      infected with Lassa virus. It can also be spread from body fluids of people with the disease.&#xD;
      Researchers want to learn more about this virus in Mali so they can develop better tools to&#xD;
      diagnose and prevent it.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To find out how many people in certain areas of southern Mali have ever had Lassa fever and&#xD;
      count how many people get the disease every year.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People ages 6 months to 99 years who live in certain areas of Mali&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Women who are could become pregnant will have a urine pregnancy test at each visit.&#xD;
&#xD;
      Participants will be asked questions about their age, if they have ever had a fever, and if&#xD;
      they have ever seen mice in or around their home. This will take about 20 minutes.&#xD;
&#xD;
      Participants will give a blood sample using a needle in a vein in the arm. Young children&#xD;
      will give it by pricking a finger or heel with a needle.&#xD;
&#xD;
      Patients with a fever illness will have a medical history and physical exam. They will give&#xD;
      blood and nasal swabs 3 times over 21 days.&#xD;
&#xD;
      Participants may be asked to come back 1 time each year for up to 3 more years to take&#xD;
      another sample of blood and answer more questions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In West Africa, as many as 300,000 people are infected annually with Lassa virus (LASV),&#xD;
      resulting in approximately 5,000 deaths. Most commonly, human infection comes from contact&#xD;
      with infected rodent hosts (Mastomys natalensis), or ingestion or inhalation of virus-laden&#xD;
      particles. Person-to-person transmission is also well documented and can cause outbreaks,&#xD;
      especially in nosocomial settings. Infection in pregnancy, especially the third trimester, is&#xD;
      particularly severe, with maternal mortality rates estimated at 20% and fetal mortality rates&#xD;
      nearing 100%. A survey of rodents captured in the village of Soromba (rural commune of&#xD;
      Sibirila, district of Bougouni, Mali) found that 25% of M. natalensis had evidence of LASV&#xD;
      infection. A 2015 study of LASV infection in the human populations of this region showed&#xD;
      seroprevalence of 33.2% and annual incidence rate of 6.3% in 2016.&#xD;
&#xD;
      The purpose of this serosurvey study is to determine the prevalence and incidence of human&#xD;
      exposure to LASV in the administrative districts of Bougouni, Yanfolila, and Kolondieba in&#xD;
      southern Mali. The study involves 2 separate sub-studies. Study 1 is a cross-sectional&#xD;
      serosurvey of residents of the general population selected from a census. The study will&#xD;
      follow up to 500 participants at each of 4 study sites (Fakola, Bamba, Filamana, and&#xD;
      Guelelinkoro). Participants will be asked to give blood samples at baseline and annually for&#xD;
      up to 3 years. Study 2 is a clinic-based serosurvey conducted at local health centers&#xD;
      following up to 500 participants per year at each of the 4 study sites (Fakola, Bamba,&#xD;
      Filamana, and Guelelinkoro). Patients who report with febrile illness suggestive of Lassa&#xD;
      fever will be asked to give blood and nasal swab samples, then return for follow-up visits 5&#xD;
      and 21 days later for clinical consultation and additional blood and swab collection.&#xD;
&#xD;
      All participants will be provided with free medical treatment according to local standard of&#xD;
      care as needed for the duration of the study. They will be followed passively between study&#xD;
      visits and instructed to report to their local health center if they have a fever. Study&#xD;
      visits will be conducted through a common end date, up to 3 years.&#xD;
&#xD;
      Blood and nasal swab samples will be used to identify history of or current LASV infection&#xD;
      and for exploratory studies into the biochemistry and pathophysiology of LASV infection.&#xD;
      Elucidating the prevalence of LASV infection in the populations of southern Mali may help&#xD;
      Malian authorities improve surveillance, and additional research may help develop diagnostics&#xD;
      and treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 4, 2020</start_date>
  <completion_date type="Anticipated">February 29, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 29, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the prevalence and</measure>
    <time_frame>At time of study start</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine the incidence of LF in febrile patients attending health centers in southern Mali</measure>
    <time_frame>Over 3 years</time_frame>
    <description>Determine the incidence of LF in febrile patients attending health centers in southern Mali over 3 years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine the biological, clinical, and virologic parameters of LASV-Soromba infection in study participants with LF.</measure>
    <time_frame>At time of study start.</time_frame>
    <description>Determine the biological, clinical, and virologic parameters of LASV-Soromba infection in study participants with LF.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">8000</enrollment>
  <condition>Lassa Virus Infection</condition>
  <arm_group>
    <arm_group_label>Clinical Cohort</arm_group_label>
    <description>This study population will consist of patient volunteers that visit one of our clinical sites with an undiagnosed febrile illness.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cross-sectional Cohort</arm_group_label>
    <description>This study population will consist of patient volunteers that visit one of our clinical sites with an undiagnosed febrile illness.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals will be randomly identified from village census lists, and a member of the&#xD;
        study team will contact the individual by phone or in person about potential participation&#xD;
        in the study. In accordance with cultural practices, the individual s entire household will&#xD;
        be invited to participate&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
               1. Age greater than or equal to 6 months to 99 years.&#xD;
&#xD;
               2. Resident of one of the study sites for at least 3 months.&#xD;
&#xD;
               3. Able to provide informed consent.&#xD;
&#xD;
               4. Agrees to allow storage of samples for future research.&#xD;
&#xD;
        Additional inclusion criteria for the cross-sectional study (study 1):&#xD;
&#xD;
        1. No plans to relocate before the study end date.&#xD;
&#xD;
        Additional inclusion criteria for the clinic-based study (study 2):&#xD;
&#xD;
          1. Has fever (temperature greater than or equal to 38 degree celcius), or has had&#xD;
             antecedent of fever for at least 2 consecutive days at the time of screening.&#xD;
&#xD;
          2. One or more of the following:&#xD;
&#xD;
               1. Excluded typhoid fever and and has at least 1 of the following symptoms: chest&#xD;
                  pain, sore throat, headache, muscle pain,vomiting, and diarrhea.&#xD;
&#xD;
               2. Shows bleeding or facial edema.&#xD;
&#xD;
               3. Does not respond to anti-malarials or antibiotics after 2 days of treatment.&#xD;
&#xD;
               4. Had contact with a confirmed LF case within the last 3 weeks.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        General exclusion criteria:&#xD;
&#xD;
          1. Any condition that, in the opinion of the investigator, contraindicates participation&#xD;
             in this study, including conditions that could hinder compliance or that could place&#xD;
             participants or study staff at increased risk.&#xD;
&#xD;
          2. Pregnancy.&#xD;
&#xD;
        Additional exclusion criteria for the clinic-based study (study 2):&#xD;
&#xD;
        1. Signs or symptoms of fever-associated conditions other than LF, such as urinary tract&#xD;
        infection, or any other infection that may cause fever.&#xD;
&#xD;
        Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study&#xD;
        staff should be notified of co-enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heinrich U Feldmann, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heinrich U Feldmann, M.D.</last_name>
    <phone>(406) 375-7410</phone>
    <email>feldmannh@mail.nih.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>Icer/Mrtc/Fmos/Usttb</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seydou Doumbia, MD</last_name>
      <phone>22376461339</phone>
      <email>sdoumbi@icermail.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Mali</country>
  </location_countries>
  <verification_date>August 13, 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Febrile</keyword>
  <keyword>Human</keyword>
  <keyword>Lassa Fever</keyword>
  <keyword>Seroconversion</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Lassa Fever</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03783143
org study id: 999919029
secondary id: 19-I-N029
nct id: NCT03783143
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Determine the prevalence and
time frame: At time of study start
description: 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
measure: Determine the incidence of LF in febrile patients attending health centers in southern Mali
time frame: Over 3 years
description: Determine the incidence of LF in febrile patients attending health centers in southern Mali over 3 years.
measure: Determine the biological, clinical, and virologic parameters of LASV-Soromba infection in study participants with LF.
time frame: At time of study start.
description: Determine the biological, clinical, and virologic parameters of LASV-Soromba infection in study participants with LF.
arm group label: Clinical Cohort
description: This study population will consist of patient volunteers that visit one of our clinical sites with an undiagnosed febrile illness.
arm group label: Cross-sectional Cohort
description: This study population will consist of patient volunteers that visit one of our clinical sites with an undiagnosed febrile illness.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Heinrich U Feldmann, M.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
last name: Heinrich U Feldmann, M.D.
phone: (406) 375-7410
email: feldmannh@mail.nih.gov
facility: 
status: Recruiting
contact: 
country: Mali
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Virus Diseases
mesh term: Lassa Fever