Blood DonorsDengSeroprevAnNCT01104740
Dengue Seroprevalence Study in Blood Donors in the French West Indies
An observational study of Blood Donors and Dengue, run by Etablissement Français du Sang, Martinique at 2 sites in 2 countries.
Trial summary
Dengue is an infectious disease most prevalent in the world. This disease is endemic in the Caribbean, with an increase in seasonal rains. Several outbreaks have been observed in recent years, in 2001, 2005 and 2007, during which further particularly virulent serotypes have emerged. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Donors, Dengue
- What is being tested?
- Biological sample collection
- How many people
- 817 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2011to May 2012
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult, résidents in Martinique/ Guadeloupe (french west indies), aged 18 to 65 years coming to give their blood in one of the building or mobile collection facilities of the French Blood Establishment in French West Indies.
Who may be able to join
- Eligible for blood donation following the French legislation,
- Resident in Martinique /Guadeloupe for at least one year
- Consent signed
Who cannot join
- Not Eligible for blood donation following the French legislation,
- Not Resident in Martinique / Guadeloupe for at least one year
- Consent not signed
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Guadeloupe1 site
French Blood Establishment of Guadeloupe
Pointe-à-Pitre, 97171
Martinique1 site
French Blood Establishment of Martinique
Fort-de-France, 97264
About this study
Dengue is an infectious disease most prevalent in the world. This disease is endemic in the Caribbean, with an increase in seasonal rains. Several outbreaks have been observed in recent years, in 2001, 2005 and 2007, during which further particularly virulent serotypes have emerged. The clinical expression of dengue fever is variable, ranging from no symptoms to a classical form with fever, and even of severe or lethal bleeding. With the possible existence of silent forms of the disease, there are no data identifying the current level of protection of the population in Martinique / Guadeloupe.
Read the detailed description
- Principal objective: To estimate the prevalence of the specific antibodies of the dengue (IgG) in blood donors in the French West Indies.
- Secondary objective:
To specify the serotypic specificity of the anti-dengue antibodies detected during the study.
- Conditions
- Blood Donors, Dengue
- Being tested
- Biological sample collection
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionOther
Blood (serum) sample collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or not of dengue virus-specific immunoglobulin G antibodies
Measured: 1 day
Secondary outcomes (1)
Characterization of dengue virus serotype-specific IgG
Characterization of dengue virus serotype-psecific IgG whendengue virus serotype-specific immunoglobulin G antibodies Test is positive
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMay 2011
- Primary completionMay 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DonorsStudies of the same condition, open and under way.
- 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
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etablissement Français du Sang, Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company, Institut National de la Santé Et de la Recherche Médicale, France, Clinique Antilles-Guyane
- Responsible party
- Principal investigator, RICHARD, Etablissement Français du Sang, Martinique
- Investigators
- Pascale RICHARD, MD, Principal investigator, French Blood Establishment of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104740
- Sponsor's protocol ID
- 10/B/01
- Other IDs
- 2010-A00385-34
- Acronym
- DengSeroprevAn
- Status last verified
- Aug 2021
- First submitted
- 14 Apr 2010
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dengue Seroprevalence Study in Blood Donors in the French West Indies
- ClinicalTrials.gov ID
- NCT01104740
- Acronym / sponsor ID
- DengSeroprevAn / 10/B/01
- Conditions
- Blood Donors, Dengue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- Etablissement Français du Sang, MartiniqueUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company, Institut National de la Santé Et de la Recherche Médicale, France, Clinique Antilles-Guyane
- Study start
- May 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Apr 2010 (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.
Dengue is an infectious disease most prevalent in the world. This disease is endemic in the Caribbean, with an increase in seasonal rains. Several outbreaks have been observed in recent years, in 2001, 2005 and 2007, during which further particularly virulent serotypes have emerged. The clinical expression of dengue fever is variable, ranging from no symptoms to a classical form with fever, and even of severe or lethal bleeding. With the possible existence of silent forms of the disease, there are no data identifying the current level of protection of the population in Martinique / Guadeloupe.
Detailed description
- Principal objective: To estimate the prevalence of the specific antibodies of the dengue (IgG) in blood donors in the French West Indies.
- Secondary objective:
To specify the serotypic specificity of the anti-dengue antibodies detected during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, résidents in Martinique/ Guadeloupe (french west indies), aged 18 to 65 years coming to give their blood in one of the building or mobile collection facilities of the French Blood Establishment in French West Indies.
Key inclusion criteria (3 listed)
- Eligible for blood donation following the French legislation,
- Resident in Martinique /Guadeloupe for at least one year
- Consent signed
Key exclusion criteria (3 listed)
- Not Eligible for blood donation following the French legislation,
- Not Resident in Martinique / Guadeloupe for at least one year
- Consent not signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sample collectionBlood (serum) sample collection | Other | – |
Primary outcome
Presence or not of dengue virus-specific immunoglobulin G antibodies
Time frame: 1 day
1 secondary outcome
Characterization of dengue virus serotype-specific IgG
Time frame: 1 day
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 20 Aug 2021.
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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.
Pascale RICHARD, MD principal investigator
French Blood Establishment of Martinique
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Donors and Dengue, run by Etablissement Français du Sang, Martinique at 2 sites in 2 countries.
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 3 inclusion and 3 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 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guadeloupe, Martinique. 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?
Presence or not of dengue virus-specific immunoglobulin G antibodies (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2021.