Dengue Virus Infection Amongst Patients With Acute Febrile Illness

Dengue Clinical Trial

Official title:

Dengue Virus Infection Amongst Patients With Acute Febrile Illness: Clinical Characteristics, Molecular and Serological Profiles for Vaccine Trial and Roll-out

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06255509
• Other study ID #: 445/068/KEP-RSUTNG
• Status: Recruiting
• Start date: February 5, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Tangerang District Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 31, 2025
• Est. primary completion date: February 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

• Patients age = 4 years old with fever (= 37.5°C), history of fever with antipyretic use, lasting less than or equal to 7 days

• Presence at least one of the following dengue-like symptoms:

• Headache

• Retro-orbital pain

• Nausea/ vomiting

• Muscle, bone, or joint pain

• Rash or bleeding manifestations

• Patient or patient's guardian giving consent to participate in the study

Exclusion Criteria:

• Have a condition that may interfere with study procedures and compliance (based on doctor's assessment)

• Suspected of focal infection

Related Conditions & MeSH terms

• Dengue
• Virus Diseases

Locations

Country	Name	City	State
Indonesia	Tangerang District Hospital	Tangerang	Banten

Sponsors (1)

Lead Sponsor	Collaborator
Tangerang District Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year
Primary	haematologic profile	leukosit absolute (number/ ul), platelet (number/ul)	1 year
Primary	Rapid test for dengue	NS1 (positive/negative), IgM (positive/negative), IgG (positive/negative)	1 year
Primary	molecular (PCR)	DEN-1 (positive/negative), DEN-2 (positive/negative), DEN-3 (positive/negative), DEN-4 (positive/negative)	1 year
Primary	PRNT	DEN-1 (titer), DEN-2 (titer), DEN-3 (titer), DEN-4 (titer)	1 year
Secondary	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	1 year