NeuMoDx PrEDiCTiNG Study Evaluation Plan

NCT03970850 | Completed DMC FDA Device

• 1 other identifier: CTNG-01-18NMD
• Study Type: interventional
• Target: 4,017
• Locations: 1 country
• Sites: 15

Brief Summary

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).

Conditions

Chlamydia Trachomatis Infection; Neisseria Gonorrheae Infection

Outcome Measures

Primary Outcomes (1)

• Clinical specificity and sensitivity

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

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Valid results rate

  Through study completion, an average of 1 year

Study Arms (3)

Multi-arm - Symptomatic and Asymptomatic Males

ACTIVE COMPARATOR

Arm 1 - Urine from males subjects

Diagnostic Test: NeuMoDx CT/NG Assay

Multi-arm - Symptomatic and Asymptomatic Females

ACTIVE COMPARATOR

Arm 2 - Endocervical, self-collected (in the clinical setting) and physician-collected vaginal swabs and urine from female subjects

Diagnostic Test: NeuMoDx CT/NG Assay

Multi-arm - FDA cleared NAATs (Comparator)

ACTIVE COMPARATOR

Arm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs)

Diagnostic Test: FDA-cleared NAATs

Interventions

NeuMoDx CT/NG Assay DIAGNOSTIC_TEST

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

Multi-arm - Symptomatic and Asymptomatic Females; Multi-arm - Symptomatic and Asymptomatic Males

FDA-cleared NAATs DIAGNOSTIC_TEST

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

Multi-arm - FDA cleared NAATs (Comparator)

Eligibility Criteria

• Age: 14 Years - 80 Years
• Gender Eligibility Details: Subjects eligible for CT/NG screening (make sure it matches the protocol)
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NeuMoDx Molecular, Inc.: lead
• NAMSA: collaborator

Study Sites (15)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Healthcare Clinical Date, Inc. (Segal Trials)

North Miami, Florida, 33161, United States

Location

Planned Parenthood - Southwest and Central Florida

Orlando, Florida, 32817, United States

Location

Planned Parenthood - Southwest and Central Florida

Tampa, Florida, 33617, United States

Location

Indiana University (IU)

Indianapolis, Indiana, 46202, United States

Location

LSU Health Science

New Orleans, Louisiana, 70112, United States

Location

NeuMoDx Molecular, Inc.

Ann Arbor, Michigan, 48108, United States

Location

Henry Ford Health System (HFHS)

Detroit, Michigan, 48202, United States

Location

Planned Parenthood - Northern, Central and Southern New Jersey

Elizabeth, New Jersey, 07201, United States

Location

Planned Parenthood - Northern, Central and Southern New Jersey

Newton, New Jersey, 07860, United States

Location

Planned Parenthood - Northern, Central and Southern New Jersey

Riverside Park, New Jersey, 08075, United States

Location

TriCore Reference Labs

Albuquerque, New Mexico, 87505, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Planned Parenthood - Gulf Coast

Houston, Texas, 77023, United States

Location

MeSH Terms

Conditions

Gonorrhea

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: July 22, 2019
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)