Clinical trial NCT01391819: Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children
Official title: An Epidemiological Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dengue
Keywords: Brazil
Incidence
Dengue virus
Dengue
Dengue infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 2117
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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).

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 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.

Primary outcomes:
measure: Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
timeFrame: At Year 1 (2012)
measure: Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
timeFrame: At Year 2 (2013)
measure: Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
timeFrame: At Year 3 (2014)
Secondary outcomes:
measure: Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
timeFrame: At Day 0 (At enrollment)
measure: Proportion of Subjects With Primary Asymptomatic Dengue Infection
timeFrame: From Day 0 to Year 3
measure: Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases
timeFrame: From Year 0 to Year 3
measure: Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
timeFrame: At Year 1 (2012)
measure: Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
timeFrame: At Year 2 (2013)
measure: Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
timeFrame: At Year 3 (2014)
measure: Number of Dengue Infection Cases by Virus Type (DENV)
timeFrame: From Day 0 to Year 3
measure: Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
timeFrame: At Year 1 (2012)
measure: Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
timeFrame: At Year 2 (2013)
measure: Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
timeFrame: At Year 3 (2014)
measure: Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
timeFrame: At Year 1 (2012)
measure: Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
timeFrame: At Year 2 (2013)
measure: Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
timeFrame: At Year 3 (2014)
measure: Number of Working Days Missed of Primary Care Giver 1 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases
timeFrame: From 21 up to 35 days post laboratory confirmed dengue onset
measure: Number of Working Days Missed of Primary Care Giver 2 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases
timeFrame: From 21 up to 35 days post laboratory confirmed dengue onset
measure: Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism
timeFrame: From 21 up to 35 days post laboratory confirmed dengue onset
measure: Number of School Days Missed by Subjects
timeFrame: From 21 up to 35 days post laboratory confirmed dengue onset
measure: Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism
timeFrame: From 21 up to 35 days post laboratory confirmed dengue onset
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 to Year 3
measure: Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource
timeFrame: From Day 0 to Year 3
measure: Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases
timeFrame: From Day 0 to Year 3
measure: Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature
timeFrame: From Day 0 to Year 3
measure: Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
timeFrame: From Day 0 to Year 3
measure: Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
timeFrame: From Day 0 to Year 3
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: GSK Investigational Site
state: Ceará
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: C B Coelho I, Haguinet F, B Colares JK, C B Coelho Z, M C Araujo F, Dias Schwarcz W, Duarte AC, Borges B, Minguet C, Guignard A. Dengue Infection in Children in Fortaleza, Brazil: A 3-Year School-Based Prospective Cohort Study. Am J Trop Med Hyg. 2020 Jul;103(1):100-111. doi: 10.4269/ajtmh.19-0521. Epub 2020 Apr 23.