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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01391819
First received: July 8, 2011
Last updated: March 16, 2017
Last verified: March 2017
  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: None (Open Label)
Primary Purpose: Other
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:
  • Number of Laboratory Confirmed Symptomatic Dengue Infection Cases [ Time Frame: At Year 1 (2012) ]
    Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling.

  • Number of Laboratory Confirmed Symptomatic Dengue Virus Cases [ Time Frame: At Year 2 (2013) ]
    Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling.

  • Number of Laboratory Confirmed Symptomatic Dengue Cases [ Time Frame: At Year 3 (2014) ]
    Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling.


Secondary Outcome Measures:
  • Number of Subjects With Immunoglobulin Type G (IgG) Antibodies Against Dengue [ Time Frame: From Day 0 to Year 3 ]
    Immune response against dengue was assessed via the Enzyme-linked Immunosorbent Assay (ELISA)

  • Number of Subjects With Asymptomatic Dengue Primary Infection [ Time Frame: From Day 0 to Year 3 ]
    Asymptomatic dengue primary infection was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits, without suspicion of dengue.

  • Number of Subjects With Laboratory Confirmed and Probable Dengue Cases [ Time Frame: From Year 0 to Year 3 ]

    A case of primary or secondary symptomatic dengue infection was defined as laboratory confirmed or probable symptomatic dengue case whose previous sample collected at scheduled Visits 1- 4 (Day 0- Year 3) to detect anti-dengue IgG antibodies was seronegative or seropositive, respectively.

    A probable dengue case was defined as a suspected symptomatic dengue case with the following laboratory findings: -anti-dengue IgM or anti-dengue IgG positivity in at least one sample (in either blood sample 1 or 2); no evidence of viremia (negative dengue virus identification through RT-qPCR) in blood sample 1; and no evidence of anti-dengue Ig M or IgG seroconversion between blood sample 1 and blood sample 2.


  • Number of Dengue Infection Cases by Virus Type [ Time Frame: From Day 0 to Year 3 ]
    Among virus types causing dengue infection were DENV-4 in 2012 and 2013 and DENV-1 in 214, as assessed by PCR.

  • Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases [ Time Frame: From Day 0 to Year 3 ]
    Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative or seropositive, respectively. Analysis was done by calendar year and age strata.

  • Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases [ Time Frame: From Day 0 to Year 3 ]
    Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative or seropositive, respectively.

  • Number of Working Days Missed of Primary Care Giver 1 and 2 [ Time Frame: Up to Day 35 post laboratory confirmed dengue onset ]
    The number of days off work from caregiver were recorded as part of health economics indirect resource utilization.

  • Caregiver Absenteeism Associated With Subject Dengue Illness [ Time Frame: Up to Day 35 post laboratory confirmed dengue onset ]
    The number of suspected dengue infections with primary caregivers missing from work was recorded as part of health economics indirect resource utilization.

  • Number of School Days Missed by Subjects [ Time Frame: Up to Day 35 post laboratory confirmed dengue onset ]
    The number of school days missed by subjects due to dengue infection were recorded as part of the dengue active surveillance.

  • Subjects Absenteeism Associated With Dengue Illness [ Time Frame: Up to Day 35 post laboratory confirmed dengue onset ]
    The number of suspected dengue infections with subjects missing from school due to dengue infection were recorded as part of the dengue active surveillance.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Year 3 ]
    Serious adverse events (SAEs) assessed include medical occurences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Direct Medical Resource Associated With Suspected Dengue Cases [ Time Frame: From Day 0 to Year 3 ]
    Direct medical resource included hospitalization, stay in intensive care units (ICU), medications, diagnostic and therapeutic procedures

  • Number of Hospitalization Days Due to Suspected Dengue Cases [ Time Frame: From Day 0 to Year 3 ]
    Length of hospitalization was part of the direct medical resource, associated with dengue infection.

  • Dengue Infection Episodes Related Temperature [ Time Frame: From Day 0 to Year 3 ]
    Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection.

  • Number of Dengue Episodes With Any Temperature Interval [ Time Frame: From Day 0 to Year 3 ]
    Temperature intervals assessed varied from hipotermia 33.5 to 36.4 degrees celsius (°C), to normal temperature 36.5-35.9 °C and hipertermia 37 - 39.9 °C, or were unknown.

  • Number of Dengue Episodes Associated With Clinical Symptoms [ Time Frame: From Day 0 to Year 3 ]
    Dengue related clinical symptoms included general symptoms, digestive symptoms, respiratory symptoms, hemorrhagic symptoms and any other signs among first symptoms.


Enrollment: 2117
Study Start Date: September 2011
Study Completion Date: January 2015
Primary Completion Date: January 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   (Child)
Sexes Eligible for Study:   All
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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01391819     History of Changes
Other Study ID Numbers: 112994
Study First Received: July 8, 2011
Results First Received: March 16, 2017
Last Updated: March 16, 2017

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

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

ClinicalTrials.gov processed this record on August 17, 2017