Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255509
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-18
Brief Title:
Dengue Virus Infection Amongst Patients With Acute Febrile Illness
Sponsor:
Tangerang District Hospital
Organization:
Tangerang District Hospital
Study Overview
Official Title:
Dengue Virus Infection Amongst Patients With Acute Febrile Illness Clinical Characteristics Molecular and Serological Profiles for Vaccine Trial and Roll-out
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Dengue is a significant public health problem in Indonesia with reported cases varies between 25000-79000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None