NCT03620487

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
643

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

3.4 years

First QC Date

May 11, 2018

Last Update Submit

February 13, 2023

Conditions

Dengue Fever

Keywords

NGSSequencing

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity of the Karius Test in detecting the Dengue Virus in plasma.

    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.

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with Dengue or Dengue Fever-like illnesses in Nepal.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tribhuvan University

Ki̇̄rtipur, Nepal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

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

Study Officials

  • Krishna Manandhar, PhD

    Tribhuvan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2018

First Posted

August 8, 2018

Study Start

October 26, 2016

Primary Completion

March 31, 2020

Study Completion

July 31, 2020

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations

NE(1)