NCT02311387

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. ...

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
601

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 5, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2018

Completed
Last Updated

December 12, 2019

Status Verified

October 22, 2018

Enrollment Period

1.9 years

First QC Date

December 5, 2014

Last Update Submit

December 11, 2019

Conditions

Lassa Virus Infection

Keywords

IncidencePrevalenceHumanMastomysSerosurvey

Outcome Measures

Primary Outcomes (3)

  • 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.

    At time of study start.

  • To determine the proportion of individuals in these villages who haveexperienced symptoms consistent with Lassa fever at the start of the study

    At time of study start.

  • 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...

    One year after study start date.

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 6 months.
  • Resident of Soromba, Bamba or Banzana with no plans to relocate within 1 year.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaria Research and Training Center

Bamako, Mali

Location

Related Publications (3)

  • Atkin S, Anaraki S, Gothard P, Walsh A, Brown D, Gopal R, Hand J, Morgan D. The first case of Lassa fever imported from Mali to the United Kingdom, February 2009. Euro Surveill. 2009 Mar 12;14(10):19145.

    PMID: 19317988BACKGROUND

  • Safronetz D, Sogoba N, Lopez JE, Maiga O, Dahlstrom E, Zivcec M, Feldmann F, Haddock E, Fischer RJ, Anderson JM, Munster VJ, Branco L, Garry R, Porcella SF, Schwan TG, Feldmann H. Geographic distribution and genetic characterization of Lassa virus in sub-Saharan Mali. PLoS Negl Trop Dis. 2013 Dec 5;7(12):e2582. doi: 10.1371/journal.pntd.0002582. eCollection 2013.

    PMID: 24340119BACKGROUND

  • Sogoba N, Feldmann H, Safronetz D. Lassa fever in West Africa: evidence for an expanded region of endemicity. Zoonoses Public Health. 2012 Sep;59 Suppl 2:43-7. doi: 10.1111/j.1863-2378.2012.01469.x.

    PMID: 22958249BACKGROUND

MeSH Terms

Conditions

Lassa Fever

Condition Hierarchy (Ancestors)

Arenaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsHemorrhagic Fevers, Viral

Study Officials

  • Heinrich U Feldmann, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 8, 2014

Study Start

December 5, 2014

Primary Completion

October 31, 2016

Study Completion

October 22, 2018

Last Updated

December 12, 2019

Record last verified: 2018-10-22

Locations

MA(1)