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Seroprevalence and Incidence of Lassa Fever in the Rural Commune of Sibirila, District of Bougouni, Mali

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ClinicalTrials.gov Identifier: NCT02311387
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : December 12, 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:

- Lassa fever is very similar to other diseases that cause fever, such as malaria and yellow fever. People get Lassa fever from mice. A person can get Lassa fever from mice urine and droppings. When a group of researchers tested the mice in Soromba, Mali, they found that many were infected with Lassa fever. Lassa fever may also be passed through body fluids (like blood or semen) of people infected with Lassa fever. Researchers want to study this disease to help the government better protect the health of people in Sibirila.

Objectives:

- To find out how many people in Sibirila have ever had Lassa fever. Also, to measure how many people get the disease every year.

Eligibility:

- People age 6 months and older who are residents of Soromba, Bamba, or Banzana with no plans to relocate within 1 year.

Design:

  • Households will be randomly selected to participate in the study.
  • Participants will have up to 20 drops of blood collected from the finger or heel.
  • Participants will be asked about their age. They will be asked if they have ever had a fever and if they have ever seen mice in or around their home.
  • Researchers will come back in 1 year and take another drop of blood from the participant. Participants will be asked the same questions.
  • If a participant has a fever at any time during the year, he or she should go to the health center. Researchers

will collect a few drops of blood to test for Lassa fever.

...


Condition or disease
Lassa Virus Infection

Detailed Description:

Throughout West Africa as many as 300,000 people are infected annually with Lassa virus, resulting in approximately 5,000 deaths. Most commonly, contact with infected rodent hosts (Mastomys natalensis), or ingestion / inhalation of virus laden particles is the source of human infection. However, person-to-person transmission is also well documented and can result in 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 Mastomys natalensis had evidence of Lassa virus infection.

The purpose of this study is to determine the proportion of people who have been previously exposed to Lassa virus, as well as the one-year incidence of infection in three villages within the rural commune of Sibirila, district of Bougouni. We will obtain 2 fingerstick blood samples (approximately one year apart) from each of approximately 600 participants aged greater than or equal to 6 months. Participants will be passively followed for one year and asked to present to their local health center if they have a fever.

Elucidation of the prevalence of Lassa virus infection in the populations living in or near Sibirila may help Malian authorities to improve surveillance and/or local diagnostics. Accurate identification of Lassa virus infections in humans will help reduce the morbidity and mortality of those living in this area.

The incidence and etiology of vector-borne diseases in southern Mali is relatively unknown. It is possible to use these samples to screen for other vector-borne diseases using similar serological assays. Expanding the testing to include filoviruses, bunyaviruses, alphaviruses and flaviviruses would greatly benefit our knowledge of circulating pathogens in southern Mali as well as the public health by helping to reduce the morbidity and mortality of those living in the area.

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Study Type : Observational
Actual Enrollment : 601 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Seroprevalence and the Incidence of Lassa Fever in the Rural Commune of Sibirila, District of Bougouni, Mali
Study Start Date : December 5, 2014
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : October 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever




Primary Outcome Measures :
  1. To determine the seroprevalence of Lassa virus infection in the population of Southern Mali at the study start date. The prevalence of Lassa virus infection will be based on serological evidence in the villages of Soromba, Bamba and Banzana. [ Time Frame: At time of study start. ]
  2. To determine the proportion of individuals in these villages who haveexperienced symptoms consistent with Lassa fever at the start of the study [ Time Frame: At time of study start. ]
  3. To determine the annual incidence of seroconversion due to Lassa virus infection. Prevalence of Lassa virus exposure at the start of the study will be compared to the prevalence at the end of one calendar year to determine the one year incidence... [ Time Frame: One year after study start date. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Age greater than or equal to 6 months.
  • Resident of Soromba, Bamba or Banzana with no plans to relocate within 1 year.

EXCLUSION CRITERIA:

  • Any condition that in the opinion of the investigator would render the participant unable to comply with the protocol (e.g., psychiatric disease).
  • Any health condition that would confound data analysis or pose unnecessary exposure risks to study personnel in the opinion of the investigator.

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): NCT02311387


Locations
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Mali
Malaria Research and Training Center
Bamako, Mali
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)
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02311387    
Other Study ID Numbers: 999915023
15-I-N023
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: October 22, 2018
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Incidence
Prevalence
Human
Mastomys
Serosurvey
Additional relevant MeSH terms:
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Lassa Fever
Virus Diseases
Arenaviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral