DengueNCT02435615
Diagnosing Dengue: Evaluating the Utility of Oral Fluid for Dengue Diagnosis
A study testing SaniSal Oral Fluid Collector in people with Dengue, run by University of Miami at 1 site in Dominican Republic.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Dengue
- What is being tested?
- SaniSal Oral Fluid Collector
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDominican Republic
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Adults that are not able to consent
- Minors without parent/guardian consent
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dengue
- Being tested
- SaniSal Oral Fluid Collector
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaniSal Oral Fluid CollectorDevice
SaniSal is an oral fluid collector used to collect oral fluid from the mouth with an absorbant sponge.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Device: SaniSal Oral Fluid Collector |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 years after the beginning of the study
Secondary outcomes (1)
Patient Acceptability of Oral Fluid Collector
Patient interviews about the acceptability of using an oral fluid collector for diagnosis
Measured: up to 2 years after beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: An unexpected Zika outbreak prevented recruitment of study participants. The samples collected were subsequently destroyed and not analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de la Diabetes, Hospital Infantil Dr. Robert Reid Cabral
- Responsible party
- Principal investigator, Justin Stoler, University of Miami
- Investigators
- Justin Stoler, PhD MPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435615
- Sponsor's protocol ID
- 20140009
- Status last verified
- Oct 2017
- First submitted
- 27 Apr 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16276520Perez-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.
PubMed 19454149Parisi 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.
PubMed 20128446Balmaseda 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.
PubMed 12626461Yap 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.
PubMed 21572982
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing Dengue: Evaluating the Utility of Oral Fluid for Dengue Diagnosis
- ClinicalTrials.gov ID
- NCT02435615
- Acronym / sponsor ID
- 20140009
- Conditions
- Dengue
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An unexpected Zika outbreak prevented recruitment of study participants. The samples collected were subsequently destroyed and not analyzed.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Instituto Nacional de la Diabetes, Hospital Infantil Dr. Robert Reid Cabral
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 May 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: SaniSal Oral Fluid CollectorThere 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Adults that are not able to consent
- Minors without parent/guardian consent
- Pregnant women
- Prisoners
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 |
|---|---|---|
| SaniSal Oral Fluid CollectorSaniSal is an oral fluid collector used to collect oral fluid from the mouth with an absorbant sponge. | Device | Study group |
Primary outcome
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.
1 secondary outcome
Patient Acceptability of Oral Fluid Collector
Time frame: up to 2 years after beginning of the study
Results and safety
The study was stopped early (reason given: An unexpected Zika outbreak prevented recruitment of study participants. The samples collected were subsequently destroyed and not analyzed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Background: PubMed 16276520Cabrera-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.
- Background: PubMed 19454149Perez-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.
- Background: PubMed 20128446Parisi 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.
- Background: PubMed 12626461Balmaseda 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.
- Background: PubMed 21572982Yap 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.
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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.
Justin Stoler, PhD MPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaniSal Oral Fluid Collector in people with Dengue, run by University of Miami at 1 site in Dominican Republic.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 26 Oct 2017. 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 Dominican Republic. 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 was stopped early (reason given: An unexpected Zika outbreak prevented recruitment of study participants. The samples collected were subsequently destroyed and not analyzed.). Results are not available in the source record.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435615, which also lists 5 linked publications.
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 26 Oct 2017.