NCT02435615

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

April 27, 2015

Last Update Submit

October 24, 2017

Conditions

Dengue

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 2 years after the beginning of the study

Secondary Outcomes (1)

  • Patient Acceptability of Oral Fluid Collector

    up to 2 years after beginning of the study

Study Arms (1)

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.

Device: SaniSal Oral Fluid Collector

Interventions

SaniSal Oral Fluid CollectorDEVICE

SaniSal is an oral fluid collector used to collect oral fluid from the mouth with an absorbant sponge.

Study group

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Infantil

Santo Domingo, Dominican Republic

Location

Related Publications (5)

  • 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.

    PMID: 16276520BACKGROUND

  • 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.

    PMID: 19454149BACKGROUND

  • 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.

    PMID: 20128446BACKGROUND

  • 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.

    PMID: 12626461BACKGROUND

  • 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.

    PMID: 21572982BACKGROUND

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Justin Stoler, PhD MPH

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Professor

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 6, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

DO(1)