DengueNCT06255509
Dengue Virus Infection Amongst Patients With Acute Febrile Illness
An observational study of Dengue, run by Tangerang District Hospital at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Dengue
- How many people
- 400 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Feb 2024to 31 Mar 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 200 hospitalized patients and 200 public health center whom fulfill inclusion criteria and exclusion criteria.
Who may be able to join
- 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
Who cannot join
- Have a condition that may interfere with study procedures and compliance (based on doctor's assessment)
- Suspected of focal infection
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Tangerang District Hospital
Tangerang, Banten, 15111
Dewi Lokida, Clinical Pathologist, +62816620605, lokidadewi@yahoo.com
Atindriya Iswari, MD, 081211025918, atindriyatriiswari@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Dengue
- Keywords
- Acute febrile illness, Dengue, Serotype
- Medical subject headings
- Dengue
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
haematologic profile
leukosit absolute (number/ ul), platelet (number/ul)
Measured: 1 year
Rapid test for dengue
NS1 (positive/negative), IgM (positive/negative), IgG (positive/negative)
Measured: 1 year
molecular (PCR)
DEN-1 (positive/negative), DEN-2 (positive/negative), DEN-3 (positive/negative), DEN-4 (positive/negative)
Measured: 1 year
PRNT
DEN-1 (titer), DEN-2 (titer), DEN-3 (titer), DEN-4 (titer)
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start5 Feb 2024 (estimated)
- Primary completion4 Feb 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Tangerang District Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255509
- Sponsor's protocol ID
- 445/068/KEP-RSUTNG
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dengue Virus Infection Amongst Patients With Acute Febrile Illness: Clinical Characteristics, Molecular and Serological Profiles for Vaccine Trial and Roll-out
- ClinicalTrials.gov ID
- NCT06255509
- Acronym / sponsor ID
- 445/068/KEP-RSUTNG
- Conditions
- Dengue
- Keywords
- Acute febrile illness, Dengue, Serotype
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tangerang District HospitalUniversity, hospital or other
- Study start
- 5 Feb 2024 (estimated)
- Primary completion
- 4 Feb 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 200 hospitalized patients and 200 public health center whom fulfill inclusion criteria and exclusion criteria.
Key inclusion criteria (8 listed)
- 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:
- Patient or patient's guardian giving consent to participate in the study
Key exclusion criteria (2 listed)
- Have a condition that may interfere with study procedures and compliance (based on doctor's assessment)
- Suspected of focal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical characteristics
Time frame: 1 year
fever (yes/no), headache (yes/no), retro-orbital pain(yes/no), nausea/ vomiting (yes/no), arthralgia/ myalgia (yes/no), bleeding manifestation (yes/no)
haematologic profile
Time frame: 1 year
leukosit absolute (number/ ul), platelet (number/ul)
Rapid test for dengue
Time frame: 1 year
NS1 (positive/negative), IgM (positive/negative), IgG (positive/negative)
molecular (PCR)
Time frame: 1 year
DEN-1 (positive/negative), DEN-2 (positive/negative), DEN-3 (positive/negative), DEN-4 (positive/negative)
PRNT
Time frame: 1 year
DEN-1 (titer), DEN-2 (titer), DEN-3 (titer), DEN-4 (titer)
1 secondary outcome
prevalence of dengue virus infection among patients with acute fever
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue, run by Tangerang District Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical characteristics (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.