Detection of Dengue Virus in Plasma of Patients in Nepal

NCT ID: NCT03620487

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

643 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-26

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dengue Fever

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tribhuvan University, Nepal

OTHER

Sponsor Role collaborator

Karius, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krishna Manandhar, PhD

Role: PRINCIPAL_INVESTIGATOR

Tribhuvan University

Locations

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Tribhuvan University

Ki̇̄rtipur, , Nepal

Site Status

Countries

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Nepal

Other Identifiers

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012-DL-01

Identifier Type: -

Identifier Source: org_study_id

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