Xpert® ERP on the GeneXpert® System

Part of paid clinical trials in Fishers, Indiana.

Sponsor
Cepheid
Study ID
NCT07489846
Status
Completed

Conditions

  • Respiratory Tract Infections

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xpert ERP — DIAGNOSTIC_TEST
    Detection and Identification of DNA and RNA from multiple bacteria and viruses from nasopharyngeal swabs

Study Details

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

Key Dates

Start date
May 13, 2025
Status verified
Mar 2026
Primary completion
Jan 28, 2026
Completion
Feb 2, 2026

Study Design

Enrollment
3,200 participants (actual)

Arms

  • Arm: Nasopharyngeal Swab Specimens
    Nasopharyngeal Swab specimens from individuals with signs and symptoms of respiratory tract infection

Primary Outcome Measure

Xpert test compared to comparator(s) tests [ Time Frame: Clinical Performance assessed on specimens collected at Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
QuantigenFishersIndiana46037-

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Quantigen· Fishers, IN

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