Dengue FeverNCT01293331
Study of Febrile Illness for Dengue-Endemic Areas in Latin America
An observational study of Dengue Fever and Fever, run by Sanofi at 18 sites in 4 countries.
Trial summary
The purpose of this study is to detect acute febrile episodes and dengue infection in five Latin American countries to assess dengue seroprevalence. Primary objectives: To identify acute febrile episodes among the cohort in order to detect the presence of dengue infection. Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever, Fever
- How many people
- 3,000 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Aug 2010to Apr 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 9 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants aged 9 to 16 years in 4 countries in Latin America: Brazil, Mexico, Colombia and Puerto Rico
Who may be able to join
- Aged 9 to 16 years on the day of inclusion and resident of the site zone
- Participant in good health, based on medical history and physical examination
- Assent form has been signed and dated by the participant (if required by local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by the participant and/or an independent witness if required by local regulations)
- Participant able to attend all scheduled visits and to comply with all study procedures
Who cannot join
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding enrollment
- Planned participation in another clinical trial during the present study period
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with study procedures
Show all 11Show fewer
- Receipt of blood or blood-derived products in the past 3 months
- Receipt of any vaccine in the 4 weeks preceding the day of enrollment except for pandemic influenza vaccination, which may be received at least 2 weeks before enrollment
- Planned receipt of any vaccine in the 4 weeks following enrollment
- Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Colombia8 sites
Study site
Acacias Meta
Study site
Aguazul (Casanare)
Study site
Bogotá
Study site
Calarco (Quindio)
Study site
Girardot (Cundinamarca)
Study site
La Tebaida (Quindio)
Study site
Montenegro (Quindio)
Study site
Yopal (Casanare)
Brazil4 sites
Study site
Campo Grande, 79074460
Study site
Goiânia, 74675-020
Study site
Natal-RN, 59025-600
Study site
Vitória, 29040-091
Mexico4 sites
Study site
Minatitlán, Veracruz Mexico, 96760
Study site
Municipio de Cd. Mante Tamaulipas
Study site
Quintana Roo
Study site
Veracruz, Veracruz Mexico, 91900
Puerto Rico2 sites
Study site
Guayama, Puerto Rico, 00784
Study site
San Juan, Puerto Rico, 00918
About this study
Official title: Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Latin America
The purpose of this study is to detect acute febrile episodes and dengue infection in five Latin American countries to assess dengue seroprevalence.
Primary objectives:
- To identify acute febrile episodes among the cohort in order to detect the presence of dengue infection.
- To describe the dengue seroprevalence among the cohort at baseline and at the end of the study.
Read the detailed description
All participants will make two visits to a study site, an enrollment visit and a termination visit. Additional visits will be made if febrile episodes occur: an acute visit and a convalescent visit. Participants or their parents/guardians will be contacted weekly to monitor the occurrence of febrile episodes and ensure appropriate assessment and care.
No vaccine will be provided or administered in this study
- Conditions
- Dengue Fever, Fever
- Keywords
- Dengue Fever Fever Seroprevalence
- Medical subject headings
- Dengue, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort (Case ) | Participants will be examined for fever in dengue endemic regions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of acute febrile episodes in the cohort
Measured: Up to 18 months after study entry
Detection of confirmed or probable dengue infection in the cohort
Measured: Up to 18 months after study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Regional Director, Study director, Sanofi Pasteur SA.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293331
- Sponsor's protocol ID
- CYD35
- Other IDs
- U1111-1112-8481
- Status last verified
- Jun 2015
- First submitted
- 9 Feb 2011
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dayan G, Arredondo JL, Carrasquilla G, Deseda CC, Dietze R, Luz K, Costa MSN, Cunha RV, Rey LC, Morales J, Reynales H, Miranda M, Zambrano B, Rivas E, Garbes P, Noriega F. Prospective cohort study with active surveillance for fever in four dengue endemic countries in Latin America. Am J Trop Med Hyg. 2015 Jul;93(1):18-23. doi: 10.4269/ajtmh.13-0663. Epub 2015 May 26.
PubMed 26013373
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Latin America
- ClinicalTrials.gov ID
- NCT01293331
- Acronym / sponsor ID
- CYD35
- Conditions
- Dengue Fever, Fever
- Keywords
- Dengue Fever Fever Seroprevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Feb 2011 (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.
The purpose of this study is to detect acute febrile episodes and dengue infection in five Latin American countries to assess dengue seroprevalence.
Primary objectives:
- To identify acute febrile episodes among the cohort in order to detect the presence of dengue infection.
- To describe the dengue seroprevalence among the cohort at baseline and at the end of the study.
Detailed description
All participants will make two visits to a study site, an enrollment visit and a termination visit. Additional visits will be made if febrile episodes occur: an acute visit and a convalescent visit. Participants or their parents/guardians will be contacted weekly to monitor the occurrence of febrile episodes and ensure appropriate assessment and care.
No vaccine will be provided or administered in this study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort (Case ) | – | –Participants will be examined for fever in dengue endemic regions |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants aged 9 to 16 years in 4 countries in Latin America: Brazil, Mexico, Colombia and Puerto Rico
Key inclusion criteria (4 listed)
- Aged 9 to 16 years on the day of inclusion and resident of the site zone
- Participant in good health, based on medical history and physical examination
- Assent form has been signed and dated by the participant (if required by local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by the participant and/or an independent witness if required by local regulations)
- Participant able to attend all scheduled visits and to comply with all study procedures
Key exclusion criteria (11 listed)
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding enrollment
- Planned participation in another clinical trial during the present study period
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
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
Identification of acute febrile episodes in the cohort
Time frame: Up to 18 months after study entry
Detection of confirmed or probable dengue infection in the cohort
Time frame: Up to 18 months after study entry
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 17 Jun 2015.
- Results publication: PubMed 26013373Dayan G, Arredondo JL, Carrasquilla G, Deseda CC, Dietze R, Luz K, Costa MSN, Cunha RV, Rey LC, Morales J, Reynales H, Miranda M, Zambrano B, Rivas E, Garbes P, Noriega F. Prospective cohort study with active surveillance for fever in four dengue endemic countries in Latin America. Am J Trop Med Hyg. 2015 Jul;93(1):18-23. doi: 10.4269/ajtmh.13-0663. Epub 2015 May 26.
- Related InfoLink provided by the sponsor.
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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.
Regional Director study director
Sanofi Pasteur SA.
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Fever and Fever, run by Sanofi at 18 sites in 4 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 4 inclusion and 11 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 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Colombia, Brazil, Mexico, Puerto Rico. 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?
Identification of acute febrile episodes in the cohort (time frame: Up to 18 months after study entry). The study lists 2 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 NCT01293331, which also lists 1 linked publication.
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 17 Jun 2015.