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Completed

NCT Number: NCT03970850

NeuMoDx PrEDiCTiNG Study Evaluation Plan

This investigational study will be conducted to evaluate the performance of the NeuMoDx™ CT/NG Assay on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (collectively referred to as NeuMoDx™ CT/NG Assay test system).

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Key information

Conditions

Chlamydia Trachomatis Infection Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseria Gonorrheae Infection Neisseriaceae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

Clinical performance characteristics of the NeuMoDx CT/NG Assay on NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System will be evaluated in a multi-center, prospective, sampling study by comparing the diagnoses made by the NeuMoDx™ CT/NG Assay to Patient Infected Status (PIS) as the reference standard.

Prospectively collected urine and swab specimens from individual subjects will be tested using the NeuMoDx™ CT/NG Assay at one of the three NeuMoDx testing sites. Subjects' PIS for CT and PIS for NG will be determined by a central laboratory using FDA-cleared, legally marketed CT/NG combo assays on pre-specified sample matrices according to the PIS determination algorithms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects of at least 14 years of age or older.
  • Subject must be able and willing to provide informed consent. The use of a 'surrogate' or 'Legally Authorized Representative' is allowed and shall follow the site's standard procedures, under which the clinical investigation will be conducted.
  • Subjects undergoing a routine pelvic examination, subjects eligible for screening evaluations for possible STDs and/or subjects known to be partners with a person with a confirmed or suspected STD.
  • Subject is willing to provide all required specimens.

Exclusion criteria

  • Female subject reports that she had a hysterectomy.
  • Subject self-reports use of antibiotics within 28 days of study enrollment.

Treatment and study plan

NeuMoDx CT/NG Assay

Diagnostic Test

NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System

FDA-cleared NAATs

Diagnostic Test

Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs

Primary outcomes

  1. Clinical specificity and sensitivity

    Time frame: Through study completion, an average of 1 year

    Clinical specificity and sensitivity of NeuMoDx CT/NG Assay for both CT and NG relative to an individual's patient infected status (PIS)

Secondary outcomes

  1. Valid results rate

    Time frame: Through study completion, an average of 1 year

    Evaluate indeterminate and unresolved rates

Sponsors and collaborators

Lead sponsor

NeuMoDx Molecular, Inc.

Industry

Collaborators

  • NAMSA

Registry information

Official study title

Multi-Center Clinical Performance Evaluation of the NeuMoDx™ Chlamydia Trachomatis (CT) / Neisseria Gonorrhoeae (NG) [CT/NG] Assay on the NeuMoDx™ 288 Molecular System and the NeuMoDx™96 Molecular System

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 3, 2019
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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