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Detection of Dengue Virus in Plasma of Patients in Nepal

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ClinicalTrials.gov Identifier: NCT03620487
Recruitment Status : Unknown
Verified August 2019 by Karius, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : August 8, 2018
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Tribhuvan University, Nepal
Information provided by (Responsible Party):
Karius, Inc.

Study Description
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Brief Summary:
To test whether Karius Infectious Disease Diagnostic Sequencing assay can detect Dengue Virus in plasma from suspected cases of Dengue or Dengue Fever like-illnesses from samples collected as part of a hospital-based multi-site study conducted in Nepal.

Condition or disease
Dengue Fever

Detailed Description:

Blood samples will be obtained from consented subjects as part of a hospital-based multi-site study conducted in Nepal and will be shipped to Karius, Redwood City, CA.

The investigators will test whether the Karius test can detect Dengue Virus in plasma from those suspected cases and measure the performance of the Karius test against standard tests (PCR, ELISA test and neutralization assays) used to determine a final diagnosis of Dengue Fever.

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pathogen Detection and Host Response in Plasma of Patients With Dengue and Dengue Fever Like Illnesses in Nepal.
Actual Study Start Date : December 21, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity and Specificity of the Karius Test in detecting the Dengue Virus in plasma. [ Time Frame: 3 years ]
    Test the sensitivity and specificity of the Karius Infectious Disease Diagnostic Sequencing Assay in detecting the Dengue Virus in plasma (measured in molecules per mL) from suspected cases of Dengue Virus from a hospital-based multicentered study conducted in Nepal.


Biospecimen Retention:   Samples With DNA
Plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with Dengue or Dengue Fever-like illnesses in Nepal.
Criteria

Inclusion Criteria:

  • 18 years and older, suspected of having Dengue or Dengue Fever-like illnesses.

Exclusion Criteria:

  • Inability to understand instructions and comply with study-related procedures, inability to understand and/or sign informed consent, any condition that will prevent the subject from completing the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620487


Locations
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Nepal
Tribhuvan University
Kirtipur, Nepal
Sponsors and Collaborators
Karius, Inc.
Tribhuvan University, Nepal
Investigators
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Principal Investigator: Krishna Manandhar, PhD Tribhuvan University
More Information
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Responsible Party: Karius, Inc.
ClinicalTrials.gov Identifier: NCT03620487    
Other Study ID Numbers: 012-DL-01
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Keywords provided by Karius, Inc.:
NGS
Sequencing
Additional relevant MeSH terms:
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Dengue
Fever
Body Temperature Changes
Arbovirus Infections
Vector Borne Diseases
Infections
 Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral