An observational study in Dengue, sponsored by Tangerang District Hospital. Recruiting at 1 site in Indonesia. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2024-02-13.
Sponsored by Tangerang District Hospital · Observational
A prospective observational study that will be conducted in Tangerang Regency, Indonesia with primary objective to determine the clinical characteristics, specific immune responses, and viral serotypes in patients with confirmed dengue virus infection in Tangerang District, Indonesia.
Dengue is a significant public health problem in Indonesia, with reported cases varies between 25.000-79.000 each year in 2013-2022. The disease is caused by four serotypes of Dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), transmitted primarily by the Aedes aegypti. However, dengue infection of DEN-4 are rarely reported compared to other dengue serotypes, such as in Vietnam, Philippines, and other Asian or other Latin American countries.
In Indonesia, DEN-4 was also the least serotypes reported. In contrast, DEN-4 is often found during dengue outbreaks. This findings has been reported in Jakarta and Jember outbreaks reports. The low prevalence of DEN-4 maybe because most studies was conducted in hospitals. Also, NS-1 RDT that is used for test has low sensitivity for DEN-4, particularly in secondary infection.
Overcoming the limitation the current diagnostic methods is critical for quick and precise treatment for individuals with dengue infection. Particularly, in the context for vaccine development and clinical trial. We chose Tangerang because it has a high risk of dengue virus transmission due to it is heavily populated area. Dengue remain a significant health problem as 50-100 cases reported each year from Public Health Centers, and >200 patients were hospitalized due to Dengue infection.
Therefore, this study will be conducted at 2 Public Health Centers (Kelapa Dua and Bojong Nangka) and Tangerang District Hospital for 1 year starting from 2 February 2024 to 31 January 2025.
Patient will be recruited when they satisfy inclusion and exclusion criteria and will be tested for RDT test and hematologic test. Blood and clinical data will be obtained from enrolled participant on enrollment and maximum 2 weeks after enrollment. Acute specimens from enrollment will be tested for NS1, IgM/ IgG using ELISA and molecular by PRNT while the convalescent specimen will be tested for IgG and IgM only. A subset of positive cases by PCR will be cultured and tested for PRNT.
Acute specimen from undiagnosed dengue infection will be tested for other pathogens.
Clinical and laboratory data will be analyzed for proportion for dengue among acute fever, proportion for each dengue serotypes, and clinical manifestation for each serotypes will be compared for severity.
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 400 is below the median of 595 across 80 observational studies indexed under Dengue.
Browse Dengue studies →This is the only study on the registry with Tangerang District Hospital as lead sponsor.
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200 hospitalized patients and 200 public health center whom fulfill inclusion criteria and exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence at least one of the following dengue-like symptoms:
Exclusion Criteria:
clinical characteristics
fever (yes/no), headache (yes/no), retro-orbital pain(yes/no), nausea/ vomiting (yes/no), arthralgia/ myalgia (yes/no), bleeding manifestation (yes/no)
Time frame: 1 year
haematologic profile
leukosit absolute (number/ ul), platelet (number/ul)
Time frame: 1 year
Rapid test for dengue
NS1 (positive/negative), IgM (positive/negative), IgG (positive/negative)
Time frame: 1 year
molecular (PCR)
DEN-1 (positive/negative), DEN-2 (positive/negative), DEN-3 (positive/negative), DEN-4 (positive/negative)
Time frame: 1 year
PRNT
DEN-1 (titer), DEN-2 (titer), DEN-3 (titer), DEN-4 (titer)
Time frame: 1 year
prevalence of dengue virus infection among patients with acute fever
prevalence of DEN-1, DEN-2, DEN-3, DEN-4 among patients with acute fever
Time frame: 1 year
PDFs hosted by the registry, ClinicalTrials.gov.
Start is estimated for Feb 2024; primary completion for Feb 2025, 11 months later.
Of 36 observational studies under Dengue, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 71. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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