Dengue FeverNCT05580731
Evaluation Study of Dengue RDTs
An observational study of Dengue Fever, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Pakistan.
Trial summary
RT-PCR and virus isolation are considered gold standard for diagnosis of Dengue from blood during first few days of infection. Serological methods such as enzyme-linked immunosorbent assays (ELISA), confirms the presence of a recent or past infection with detection of NS1 antigen and anti-dengue antibodies. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Dengue Fever
- What is being tested?
- Diagnostic test: 5 different Rapid diagnostic test and Reference tests
- How many people
- 430 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Jul 2022to 28 Jun 2023
- 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 2 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: The study will be conducted at AKU research laboratory using leftover serum samples, which were archived for further research purposes for previous trial "Comparative study of commercially available typhoid point of care tests to benchmark current and emerging tools" conducted at AKU in 2020-2021. Precisely, the population is represented by children and adults (age 2-65) who presented with fever of 3-7 days duration. All patients from whom these samples were obtained have consented to store their sample at AKU and to use them for research on diagnostic tool for fever management.
Who may be able to join
- Have been obtained from patients presented with fever of < 1 week who have given consent for sample storage for further research purpose.
- Have minimum sample volume of 1 ml.
- Are non-haemolytic
- Have a limited number of freeze-thaw cycles (<3)
- Have been stored at or below -200C
Who cannot join
- Only samples that meet the inclusion criteria listed above will be selected for the study. Therefore, samples in the study site sample archives which do not meet these criteria will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Study of Commercially Available Rapid Diagnostic Tests (RDTs) Detecting Antigen and Antibodies Against Dengue Virus
RT-PCR and virus isolation are considered gold standard for diagnosis of Dengue from blood during first few days of infection. Serological methods such as enzyme-linked immunosorbent assays (ELISA), confirms the presence of a recent or past infection with detection of NS1 antigen and anti-dengue antibodies. However, these methods are time-consuming and need significant laboratory infrastructure, including instrumentation, trained personnel and refrigeration for reagents. Hence, in areas where DENV is endemic, have limited resources and inadequate laboratory capacity to perform these tests, rapid diagnostic tests (RDTs) can be used for quick and simple screening. Recently various RDTs which detect Antigen (NS1) and Antibodies (IgM and IgG) in single format are widely available and in use, but the performance data are not available or not consistent from one study to another. Therefore, this study aims to evaluate the sensitivity and specificity of different RDTs that detect antigens and antibodies to Dengue viruses in one cassette during acute febrile stage thereby helping healthcare providers to decide on the best test.
Read the detailed description
Dengue is an emerging infectious disease and is endemic to more than 100 tropical nations. It is a serious public health issue, with an estimated global incidence of > 100 million in 2016, a rise of almost 60% in age-standardized rates since 2006. While rising dengue infection rates affect all major regions of the world, the Asia-Pacific region is disproportionately affected by severe dengue, with rates 18 times higher in Southeast Asia than in the Americas. Climate change and globalization has facilitated the geographic spread of both the mosquito vector and the pathogen to previously unaffected areas, thereby increasing the number of people affected by dengue. Unfortunately, no specific antiviral medication and vaccine exists for Dengue. Hence, an accurate and early diagnosis is essential for proper and timely management and control of the disease in endemic regions. Dengue causes wide spectrum of disease. Primary dengue can range from sub clinical disease to flu-like symptoms. Although less common secondary dengue is associated with increased mortality and morbidity. Accurate, efficient, and rapid diagnosis of dengue in the acute stage is essential as a delay in diagnosis increases the risk of severe dengue and can lead to poor disease outcome. The most commonly used tests to diagnose acute dengue infection are commercial ELISA. Many Dengue RDTs came in rise and flooded the market in the past two decades due to the growing demand for point-of-care diagnostics. RDT is the easiest and most cost-effective method for diagnosis of this virus infection. It is user-friendly, requires no equipment and provide results faster than PCR and ELISA. Different format of Dengue RDTs are available in the market which can detect NS1, IgM and IgG. Detection of NS1, IgM and IgG in single RDT, not only detects primary dengue but also detects past dengue infection and can be helpful in disease prognosis. Many studies have been conducted previously focusing on individual markers of dengue RDTs and not the combined assessment of the test. This has significantly impeded healthcare providers to decide on deciding which overall tests is best to diagnose acute dengue and detects past dengue in a single test format. Hence, this study will aim to perform a head-to-head comparison of Dengue RDTs which detects antigen and antibodies in single test format currently in the market to diagnose acute dengue to help stakeholder decision making more broadly.
- Conditions
- Dengue Fever
- Being tested
- Diagnostic test: 5 different Rapid diagnostic test and Reference tests
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test: 5 different Rapid diagnostic test and Reference testsDiagnostic test
Diagnostic test: 5 different Rapid diagnostic test and Reference tests
What is being measured
The primary outcome is the main question the study is designed to answer.
Point estimates of sensitivity and specificity of each RDTs to detect acute dengue with 95% confidence intervals using ELISA as reference standard.
Point estimates of sensitivity and specificity, with 95% confidence intervals based on Wilson's score methods, will be calculated
Measured: 7 months
Secondary outcomes (1)
Estimates of operational characteristics of different RDTs, based on quantitative assessment including invalid rates
Rate of invalid runs: Percent of invalid runs per RDTs
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start31 Jul 2022
- Primary completion24 Feb 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University
- Responsible party
- Sponsor
- Investigators
- Rumina Hasan, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580731
- Sponsor's protocol ID
- FE006B
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study of Commercially Available Rapid Diagnostic Tests (RDTs) Detecting Antigen and Antibodies Against Dengue Virus
- ClinicalTrials.gov ID
- NCT05580731
- Acronym / sponsor ID
- FE006B
- Conditions
- Dengue Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Aga Khan University
- Study start
- 31 Jul 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 14 Oct 2022 (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.
RT-PCR and virus isolation are considered gold standard for diagnosis of Dengue from blood during first few days of infection. Serological methods such as enzyme-linked immunosorbent assays (ELISA), confirms the presence of a recent or past infection with detection of NS1 antigen and anti-dengue antibodies. However, these methods are time-consuming and need significant laboratory infrastructure, including instrumentation, trained personnel and refrigeration for reagents. Hence, in areas where DENV is endemic, have limited resources and inadequate laboratory capacity to perform these tests, rapid diagnostic tests (RDTs) can be used for quick and simple screening. Recently various RDTs which detect Antigen (NS1) and Antibodies (IgM and IgG) in single format are widely available and in use, but the performance data are not available or not consistent from one study to another. Therefore, this study aims to evaluate the sensitivity and specificity of different RDTs that detect antigens and antibodies to Dengue viruses in one cassette during acute febrile stage thereby helping healthcare providers to decide on the best test.
Detailed description
Dengue is an emerging infectious disease and is endemic to more than 100 tropical nations. It is a serious public health issue, with an estimated global incidence of > 100 million in 2016, a rise of almost 60% in age-standardized rates since 2006. While rising dengue infection rates affect all major regions of the world, the Asia-Pacific region is disproportionately affected by severe dengue, with rates 18 times higher in Southeast Asia than in the Americas. Climate change and globalization has facilitated the geographic spread of both the mosquito vector and the pathogen to previously unaffected areas, thereby increasing the number of people affected by dengue. Unfortunately, no specific antiviral medication and vaccine exists for Dengue. Hence, an accurate and early diagnosis is essential for proper and timely management and control of the disease in endemic regions. Dengue causes wide spectrum of disease. Primary dengue can range from sub clinical disease to flu-like symptoms. Although less common secondary dengue is associated with increased mortality and morbidity. Accurate, efficient, and rapid diagnosis of dengue in the acute stage is essential as a delay in diagnosis increases the risk of severe dengue and can lead to poor disease outcome. The most commonly used tests to diagnose acute dengue infection are commercial ELISA. Many Dengue RDTs came in rise and flooded the market in the past two decades due to the growing demand for point-of-care diagnostics. RDT is the easiest and most cost-effective method for diagnosis of this virus infection. It is user-friendly, requires no equipment and provide results faster than PCR and ELISA. Different format of Dengue RDTs are available in the market which can detect NS1, IgM and IgG. Detection of NS1, IgM and IgG in single RDT, not only detects primary dengue but also detects past dengue infection and can be helpful in disease prognosis. Many studies have been conducted previously focusing on individual markers of dengue RDTs and not the combined assessment of the test. This has significantly impeded healthcare providers to decide on deciding which overall tests is best to diagnose acute dengue and detects past dengue in a single test format. Hence, this study will aim to perform a head-to-head comparison of Dengue RDTs which detects antigen and antibodies in single test format currently in the market to diagnose acute dengue to help stakeholder decision making more broadly.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted at AKU research laboratory using leftover serum samples, which were archived for further research purposes for previous trial "Comparative study of commercially available typhoid point of care tests to benchmark current and emerging tools" conducted at AKU in 2020-2021. Precisely, the population is represented by children and adults (age 2-65) who presented with fever of 3-7 days duration. All patients from whom these samples were obtained have consented to store their sample at AKU and to use them for research on diagnostic tool for fever management.
Key inclusion criteria (5 listed)
- Have been obtained from patients presented with fever of < 1 week who have given consent for sample storage for further research purpose.
- Have minimum sample volume of 1 ml.
- Are non-haemolytic
- Have a limited number of freeze-thaw cycles (<3)
- Have been stored at or below -200C
Key exclusion criteria (1 listed)
- Only samples that meet the inclusion criteria listed above will be selected for the study. Therefore, samples in the study site sample archives which do not meet these criteria will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic test: 5 different Rapid diagnostic test and Reference testsDiagnostic test: 5 different Rapid diagnostic test and Reference tests | Diagnostic test | – |
Primary outcome
Point estimates of sensitivity and specificity of each RDTs to detect acute dengue with 95% confidence intervals using ELISA as reference standard.
Time frame: 7 months
Point estimates of sensitivity and specificity, with 95% confidence intervals based on Wilson's score methods, will be calculated
1 secondary outcome
Estimates of operational characteristics of different RDTs, based on quantitative assessment including invalid rates
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Dengue Fever
Active, not recruitingPhase 3
A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)
Dengue Fever
RecruitingPhase 2
Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2)
Dengue Fever
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Active, not recruitingObservational study
Bridging Economics and Public Trust: A Study of Dengue Vaccine Cost-effectiveness and Acceptance in Thais Visiting Hospital
Dengue Fever
RecruitingObservational study
Gut Leakage' in Dengue
Dengue, Dengue Hemorrhagic Fever
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.
Rumina Hasan principal investigator
Aga Khan University
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 Fever, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Pakistan.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 21 Nov 2023. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point estimates of sensitivity and specificity of each RDTs to detect acute dengue with 95% confidence intervals using ELISA as reference standard. (time frame: 7 months). 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 21 Nov 2023; AzTrials last refreshed its copy on 27 Oct 2026.