Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01391819
First received: July 8, 2011
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

The aim of this study is to establish an active surveillance in order to generate dengue disease burden estimates including incidence rates, prevalence data, clinical presentation and cost of illness in Forteleza (Brazil).


Condition Intervention
Dengue
Other: Data collection
Procedure: Blood sample collection

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Epidemiological Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of laboratory-confirmed symptomatic dengue infection [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of past dengue infections [ Time Frame: At least three years ] [ Designated as safety issue: No ]
  • Occurrence of asymptomatic primary dengue infection [ Time Frame: At least three years ] [ Designated as safety issue: No ]
  • Occurrence of symptomatic dengue infection by virus type [ Time Frame: At least three years ] [ Designated as safety issue: No ]
  • Occurrence of symptomatic and primary asymptomatic dengue infection by age category [ Time Frame: At least three years ] [ Designated as safety issue: No ]
  • Occurrence of primary symptomatic dengue infections [ Time Frame: At least three years ] [ Designated as safety issue: No ]
  • Occurrence of secondary symptomatic dengue infections [ Time Frame: At least three years ] [ Designated as safety issue: No ]
  • Symptoms of symptomatic dengue infection [ Time Frame: At least three years ] [ Designated as safety issue: No ]
  • Direct medical resource utilization and indirect resource utilization associated with symptomatic dengue infection [ Time Frame: At least three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: September 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study cohort
Children age 5 to 13 years at the time of enrollment, selected from schools in Fortaleza.
Other: Data collection
Socio-demographic information, medical history, yellow fever vaccination history and dengue suspicion data collection.
Procedure: Blood sample collection
A blood sample will be collected at each of the three scheduled study visits and any time during the study that dengue is suspected. Samples collected at scheduled visits will be tested for anti-dengue antibodies. Samples collected at visits for dengue suspicion will be tested for dengue diagnosis.

Detailed Description:

Prospective cohort study.

The study period initially planned to be two years, is extended by one year to cover one additional dengue season.

  Eligibility

Ages Eligible for Study:   5 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between 5 and 13 years of age (including children at least 5 years of age and excluding children who reached their fourteenth birthday) at the time of enrollment.
  • Written informed consent (and assent when applicable).
  • Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol (e.g. willingness to do a hospital visit in case of dengue suspicion, willingness to attend the study hospital return for follow-up visits, able to observe for signs of dengue, understand how to take a temperature, etc).
  • Subjects who plan to attend one of the study schools for two school years following enrollment.

Exclusion Criteria:

  • Subjects planning to move from the study area during the two school years following enrollment.
  • Child in care.
  • Enrollment in another study that would conflict with the current study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391819

Locations
Brazil
GSK Investigational Site
Fortaleza, Ceará, Brazil, 60430 160
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01391819     History of Changes
Other Study ID Numbers: 112994
Study First Received: July 8, 2011
Last Updated: July 3, 2014
Health Authority: Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)

Keywords provided by GlaxoSmithKline:
Brazil
Incidence
Dengue virus
Dengue
Dengue infection

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Flaviviridae Infections
Flavivirus Infections
Hemorrhagic Fevers, Viral
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014