NCT07489846

Brief Summary

A multi-site observational all-comers study that will be conducted at geographically diverse sites within the United States

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 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

May 13, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Xpert test compared to comparator(s) tests

    Evaluating the clinical performance (PPA and NPA) of Xpert ERP relative to comparator(s)

    Clinical Performance assessed on specimens collected at Baseline

Study Arms (1)

Nasopharyngeal Swab Specimens

Nasopharyngeal Swab specimens from individuals with signs and symptoms of respiratory tract infection

Diagnostic Test: Xpert ERP

Interventions

Xpert ERPDIAGNOSTIC_TEST

Detection and Identification of DNA and RNA from multiple bacteria and viruses from nasopharyngeal swabs

Nasopharyngeal Swab Specimens

Eligibility Criteria

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

Specimens collected from individuals with signs and symptoms of respiratory tract infection

You may qualify if:

  • NPS specimen from participant who presents with signs and symptoms of RTI
  • NPS specimen collected in commercially available UTM/VTM only

You may not qualify if:

  • NPS specimen collected from a participant previously enrolled in this study
  • Principal Investigator feels the participant is not suitable to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quantigen

Fishers, Indiana, 46037, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal Swab specimens collected from consented individuals with sign and symptoms of respiratory tract infection

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

May 13, 2025

Primary Completion

January 28, 2026

Study Completion

February 2, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)