Dengue Virus Infection Amongst Patients With Acute Febrile Illness

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dengue

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Indonesia
  • Banten
    • Tangerang, Banten, Indonesia, 15111
      • Recruiting
      • Tangerang District Hospital
      • Contact: Dewi Lokida, Clinical Pathologist; Phone Number: +62816620605; Email: lokidadewi@yahoo.com
      • Contact: Atindriya Iswari, MD; Phone Number: 081211025918; Email: atindriyatriiswari@gmail.com
      • Principal Investigator: Dewi Lokida, Clinical Pathologist
      • Principal Investigator: Herman Kosasih, PhD
      • Principal Investigator: Achmad Muchlis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

200 hospitalized patients and 200 public health center whom fulfill inclusion criteria and exclusion criteria.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tangerang District Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 5, 2024
• Primary Completion (Estimated): February 4, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dengue; Serotype; Acute febrile illness
• Additional Relevant MeSH Terms: RNA Virus Infections; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Virus Diseases; Dengue
• Other Study ID Numbers: 445/068/KEP-RSUTNG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No