NCT07370454

Brief Summary

A multi-site observation study that was conducted a geographically diverse sites across the United States

Trial Health

87
On Track

Trial Health Score

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

Enrollment
408

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

October 17, 2025

Last Update Submit

January 22, 2026

Conditions

Hemorrhagic Fever

Outcome Measures

Primary Outcomes (1)

  • Clinical performance comparing Xpert Hemorrhagic Fever to known status of specimens

    Xpert test compared to expected status

    Clinical Performance assessed in specimens collected at Baseline

Study Arms (1)

Capillary and venous whole blood specimens

whole blood specimens from individuals asymptomatic or symptomatic of fever

Diagnostic Test: Xpert Hemorrhagic Fever test

Interventions

Xpert Hemorrhagic Fever testDIAGNOSTIC_TEST

Detection and identification of RNA from multiple viruses from whole blood specimens

Capillary and venous whole blood specimens

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Whole blood specimens collected from blood donors symptomatic or asymptomatic of fever

You may qualify if:

  • Capillary and venous whole blood specimens from blood donors who symptomatic for fever lasting ≤ 10 days OR asymptomatic for fever
  • Whole blood specimens collected in EDTA specimens collection devices only

You may not qualify if:

  • Any whole blood specimens from blood donors vaccinated with a Hemorrhagic Fever live virus vaccine within the past 28 days
  • Any whole blood specimen that were previously enrolled
  • Any whole blood specimens not collected according to the manufacturer's instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USAMRIID

Frederick, Maryland, 21702, United States

Location

MeSH Terms

Conditions

Hemorrhagic Fevers, Viral

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfections

Study Design

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

Study Record Dates

First Submitted

October 17, 2025

First Posted

January 27, 2026

Study Start

January 13, 2025

Primary Completion

April 29, 2025

Study Completion

October 3, 2025

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)