Diagnosing Dengue: Evaluating the Utility of Oral Fluid for Dengue Diagnosis

October 24, 2017 updated by: Justin Stoler, University of Miami
Dengue is the most common viral illness spread by mosquitos. It is important to diagnose dengue to prompt adequate therapy and initiate local mosquito control. Easy to use point of care tests are needed to improve dengue diagnosis. Oral fluid collection may be a simple, non-invasive way to diagnose dengue in the community. However, it is currently unknown if oral fluid is an accurate way to diagnose dengue and if the use of a specialized oral fluid collector could help to improve dengue diagnosis. In this study, the investigators will analyze the oral fluid of suspected dengue patients compared to serum samples for dengue diagnosis. From this information the investigators will be able to determine if oral fluid is a convenient way to diagnose dengue and if the oral fluid collector aids in improving diagnosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dengue continues to spread and threaten approximately 3.6 billion people. It is crucial to adequately recognize dengue and start early intervention. Dengue virus (DENV) infections are typically confirmed by virus isolation and nucleic acid detection, both of which require trained personnel and advanced facilities that are limited in developing countries. Detection of antibodies serves as a viable and cheaper diagnostic alternative, and one method of doing so is through oral fluid. Detecting DENV antibodies in oral fluid has been accomplished. The utility of oral fluids is attractive as specimens can be acquired in a faster, non-invasive manner that is suitable for children and needle-phobic adults. One challenge of using oral fluid for dengue diagnosis is that typically, oral fluid contains the same analytes found in blood, albeit in lower concentrations, thus there is a need for protein concentration if oral fluid will be used for diagnosis.

A device capable of collecting oral fluid is the Sani-Sal® oral fluid collector, used successfully in rapid diagnostics of HIV. It is a unique device that claims to concentrate oral fluid proteins, decrease oral fluid viscosity, and stimulate salivation. These properties make the Sani-Sal® potentially valuable in the diagnosis of DENV in the field by concentrating antibodies to identify early infection.

Furthermore, dengue is commonly misdiagnosed or undiagnosed given varying clinical manifestations, lack of patient health seeking behavior, and lack of incentives for physicians to confirm and report cases. Knowledge on the health-seeking behaviors of dengue patients remains limited. The project will also assess patient and practitioner perceptions regarding dengue diagnostics, care, and reporting while considering the utility of this novel diagnostic technology. Lastly, the study will seek to understand the role of governance in communicable disease surveillance, reporting and information flow.

This application seeks approval to pilot a study which will seek to determine whether the SaniSal® can be useful in DENV diagnosis by concentrating DENV IgM antibodies and NS1 antigens. The study will also like to explore the knowledge, attitude, practices and health seeking behaviors of patients, while understanding dengue training, diagnosis and reporting amongst practitioners. The study will be conducted in partnership with the Instituto Nacional de Diabetes (INDEN) and Dr. Roberto Reid Cabral's Children's Hospital in Santo Domingo, Dominican Republic-where dengue is endemic.

The utility of oral-fluid in diagnostics is promising: it can serve as efficient tools for point-of-care practices and as an alternative to blood-draw. If this study shows that saliva can be equally effective in the detection of DENV as blood on an ELISA confirmatory test, then the investigators can mitigate the limitations of serum testing. This can result in increased rapid diagnostic confirmation of suspected cases, improving on patient comfort and care while assisting in targeted vector control. This coupled with insights on policies, perceptions and behaviors surrounding DENV can help improve point-of-care diagnostics, reporting and surveillance, and community education efforts during epidemics in endemic countries of the Caribbean region.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Febrile for at least 36 hours with clinical characteristics of dengue
  • Presents for care at the hospital during time of study
  • Over the age of 2 years old
  • Adults are able and willing to consent or a parent/guardian is willing and able to accept consent for a child.

Exclusion Criteria:

  • Adults that are not able to consent
  • Minors without parent/guardian consent
  • Pregnant women
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study group
There is one group of patients which are those presenting to the hospital with suspected clinical case of dengue fever for diagnosis. This group will have oral fluid collected via the SaniSal oral fluid collector and a pipette, and blood collected via venipuncture.
Device: SaniSal Oral Fluid Collector
SaniSal is an oral fluid collector used to collect oral fluid from the mouth with an absorbant sponge.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dengue Immunoglobulin M (IgM) and Non-Structural Protein 1 (NS1) Concentration in Oral Fluid
Time Frame: up to 2 years after the beginning of the study
IgM and NS1 Concentration via ELISA from oral fluid collected via the SaniSal Oral Fluid collector versus pipette compared to serum concentration.
up to 2 years after the beginning of the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Acceptability of Oral Fluid Collector
Time Frame: up to 2 years after beginning of the study
Patient interviews about the acceptability of using an oral fluid collector for diagnosis
up to 2 years after beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Infantil Dr. Robert Reid Cabral
Instituto Nacional de la Diabetes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Justin Stoler, PhD MPH, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20140009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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