N/A
N=2,116
Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children
Dengue
Bottom Line
View on ClinicalTrials.gov: NCT01391819 ↗Enrolled (actual)
2,116
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Incidence of All Laboratory-confirmed Symptomatic Dengue Infection — 10.5; 11.5 Cases in 1000 person-years
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Data collection (Other); Blood sample collection (Procedure)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of All Laboratory-confirmed Symptomatic Dengue Infection |
3.9; 14.1 | — |
| PRIMARY Incidence of All Laboratory-confirmed Symptomatic Dengue Infection |
3.9; 14.1 | — |
| PRIMARY Incidence of All Laboratory-confirmed Symptomatic Dengue Infection |
3.9; 14.1 | — |
| SECONDARY Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment |
32.57; 45.18; 38.86; 49.60; 50.20; 57.27 | — |
| SECONDARY Proportion of Subjects With Primary Asymptomatic Dengue Infection |
20.27; 8.70; 5.14; 13.09 | — |
| SECONDARY Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases |
23; 19; 33; 109; 1; 3 | — |
| SECONDARY Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection |
13.6; 33.1 | — |
| SECONDARY Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection |
13.6; 33.1 | — |
| SECONDARY Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection |
13.6; 33.1 | — |
| SECONDARY Number of Dengue Infection Cases by Virus Type (DENV) |
8; 6; 7 | — |
| SECONDARY Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases |
2; 2 | — |
| SECONDARY Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases |
2; 2 | — |
| SECONDARY Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases |
2; 2 | — |
| SECONDARY Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases |
0; 10 | — |
| SECONDARY Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases |
0; 10 | — |
| SECONDARY Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases |
0; 10 | — |
| SECONDARY Number of Working Days Missed of Primary Care Giver 1 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases |
2.4 | — |
| SECONDARY Number of Working Days Missed of Primary Care Giver 2 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases |
1.8 | — |
| SECONDARY Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism |
12; 42; 3; 0; 4; 46 | — |
| SECONDARY Number of School Days Missed by Subjects |
4.4 | — |
| SECONDARY Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism |
49; 5; 3; 0 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
— | — |
| SECONDARY Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource |
2; 54; 1; 1; 1; 55 | — |
| SECONDARY Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases |
19.0 | — |
| SECONDARY Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature |
37.18 | — |
| SECONDARY Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases |
0; 0; 0; 2; 2; 8 | — |
| SECONDARY Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms |
43; 22; 29; 10; 7; 3 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT01391819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.