Lassa Virus InfectionNCT02311387
Seroprevalence and Incidence of Lassa Fever in the Rural Commune of Sibirila, District of Bougouni, Mali
An observational study of Lassa Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Lassa Virus Infection
- How many people
- 601 participants
- Where
- 1 siteMali
- Study dates
- 5 Dec 2014to 22 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 6 months.
- Resident of Soromba, Bamba or Banzana with no plans to relocate within 1 year.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Seroprevalence and the Incidence of Lassa Fever in the Rural Commune of Sibirila, District of Bougouni, Mali
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.
Read more
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.
...
Read the 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.
- Conditions
- Lassa Virus Infection
- Keywords
- Incidence, Prevalence, Human, Mastomys, Serosurvey
- Medical subject headings
- Lassa Fever
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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...
Measured: One year after study start date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start5 Dec 2014
- Primary completion31 Oct 2016
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lassa Virus InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Heinrich U Feldmann, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311387
- Sponsor's protocol ID
- 999915023
- Other IDs
- 15-I-N023
- Status last verified
- 22 Oct 2018
- First submitted
- 5 Dec 2014
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
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.
PubMed 19317988Safronetz 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.
PubMed 24340119Sogoba 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.
PubMed 22958249
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Seroprevalence and the Incidence of Lassa Fever in the Rural Commune of Sibirila, District of Bougouni, Mali
- ClinicalTrials.gov ID
- NCT02311387
- Acronym / sponsor ID
- 999915023
- Conditions
- Lassa Virus Infection
- Keywords
- Incidence, Prevalence, Human, Mastomys, Serosurvey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 5 Dec 2014
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 6 months.
- Resident of Soromba, Bamba or Banzana with no plans to relocate within 1 year.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 19317988Atkin 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.
- Background: PubMed 24340119Safronetz 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.
- Background: PubMed 22958249Sogoba 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinrich U Feldmann, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lassa Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02311387, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.