Diagnosing Dengue: Evaluating the Utility of Oral Fluid for Dengue Diagnosis
Primary Purpose
Dengue
Status
Terminated
Phase
Not Applicable
Locations
Dominican Republic
Study Type
Interventional
Intervention
SaniSal Oral Fluid Collector
Sponsored by
About this trial
This is an interventional diagnostic trial for Dengue
Eligibility Criteria
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
Sites / Locations
- Hospital Infantil
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
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.
Outcomes
Primary Outcome Measures
Dengue Immunoglobulin M (IgM) and Non-Structural Protein 1 (NS1) Concentration in Oral Fluid
IgM and NS1 Concentration via ELISA from oral fluid collected via the SaniSal Oral Fluid collector versus pipette compared to serum concentration.
Secondary Outcome Measures
Patient Acceptability of Oral Fluid Collector
Patient interviews about the acceptability of using an oral fluid collector for diagnosis
Full Information
NCT ID
NCT02435615
First Posted
April 27, 2015
Last Updated
October 24, 2017
Sponsor
University of Miami
Collaborators
Instituto Nacional de la Diabetes, Hospital Infantil Dr. Robert Reid Cabral
1. Study Identification
Unique Protocol Identification Number
NCT02435615
Brief Title
Diagnosing Dengue: Evaluating the Utility of Oral Fluid for Dengue Diagnosis
Official Title
Diagnosing Dengue: Evaluating the Utility of Oral Fluid for Dengue Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
An unexpected Zika outbreak prevented recruitment of study participants. The samples collected were subsequently destroyed and not analyzed.
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Instituto Nacional de la Diabetes, Hospital Infantil Dr. Robert Reid Cabral
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SaniSal Oral Fluid Collector
Intervention Description
SaniSal is an oral fluid collector used to collect oral fluid from the mouth with an absorbant sponge.
Primary Outcome Measure Information:
Title
Dengue Immunoglobulin M (IgM) and Non-Structural Protein 1 (NS1) Concentration in Oral Fluid
Description
IgM and NS1 Concentration via ELISA from oral fluid collected via the SaniSal Oral Fluid collector versus pipette compared to serum concentration.
Time Frame
up to 2 years after the beginning of the study
Secondary Outcome Measure Information:
Title
Patient Acceptability of Oral Fluid Collector
Description
Patient interviews about the acceptability of using an oral fluid collector for diagnosis
Time Frame
up to 2 years after beginning of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Stoler, PhD MPH
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Infantil
City
Santo Domingo
Country
Dominican Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
16276520
Citation
Cabrera-Batista B, Skewes-Ramm R, Fermin CD, Garry RF. Dengue in the Dominican Republic: epidemiology for 2004. Microsc Res Tech. 2005 Nov;68(3-4):250-4. doi: 10.1002/jemt.20225.
Results Reference
background
PubMed Identifier
19454149
Citation
Perez-Guerra CL, Zielinski-Gutierrez E, Vargas-Torres D, Clark GG. Community beliefs and practices about dengue in Puerto Rico. Rev Panam Salud Publica. 2009 Mar;25(3):218-26. doi: 10.1590/s1020-49892009000300005.
Results Reference
background
PubMed Identifier
20128446
Citation
Parisi MR, Soldini L, Di Perri G, Tiberi S, Lazzarin A, Lillo FB. Offer of rapid testing and alternative biological samples as practical tools to implement HIV screening programs. New Microbiol. 2009 Oct;32(4):391-6.
Results Reference
background
PubMed Identifier
12626461
Citation
Balmaseda A, Guzman MG, Hammond S, Robleto G, Flores C, Tellez Y, Videa E, Saborio S, Perez L, Sandoval E, Rodriguez Y, Harris E. Diagnosis of dengue virus infection by detection of specific immunoglobulin M (IgM) and IgA antibodies in serum and saliva. Clin Diagn Lab Immunol. 2003 Mar;10(2):317-22. doi: 10.1128/cdli.10.2.317-322.2003.
Results Reference
background
PubMed Identifier
21572982
Citation
Yap G, Sil BK, Ng LC. Use of saliva for early dengue diagnosis. PLoS Negl Trop Dis. 2011 May 10;5(5):e1046. doi: 10.1371/journal.pntd.0001046.
Results Reference
background
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Diagnosing Dengue: Evaluating the Utility of Oral Fluid for Dengue Diagnosis
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