NeuMoDx PrEDiCTiNG Study Evaluation Plan

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

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).

Study Overview

• Status: Completed
• Conditions: Neisseria Gonorrheae Infection; Chlamydia Trachomatis Infection
• Intervention / Treatment: Diagnostic test: NeuMoDx CT/NG Assay; Diagnostic test: FDA-cleared NAATs

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 4017
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • Florida
    • North Miami, Florida, United States, 33161
      • Healthcare Clinical Date, Inc. (Segal Trials)
    • Orlando, Florida, United States, 32817
      • Planned Parenthood - Southwest and Central Florida
    • Tampa, Florida, United States, 33617
      • Planned Parenthood - Southwest and Central Florida
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University (IU)
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • LSU Health Science
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • NeuMoDx Molecular, Inc.
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System (HFHS)
  • New Jersey
    • Delran, New Jersey, United States, 08075
      • Planned Parenthood - Northern, Central and Southern New Jersey
    • Elizabeth, New Jersey, United States, 07201
      • Planned Parenthood - Northern, Central and Southern New Jersey
    • Newton, New Jersey, United States, 07860
      • Planned Parenthood - Northern, Central and Southern New Jersey
  • New Mexico
    • Albuquerque, New Mexico, United States, 87505
      • TriCore Reference Labs
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
  • Texas
    • Houston, Texas, United States, 77023
      • Planned Parenthood - Gulf Coast

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female subjects of at least 14 years of age or older.
2. 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.
3. 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.
4. Subject is willing to provide all required specimens.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Multi-arm - Symptomatic and Asymptomatic Males; Arm 1 - Urine from males subjects	Diagnostic test: NeuMoDx CT/NG Assay; NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System
Active Comparator: Multi-arm - Symptomatic and Asymptomatic Females; 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; NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System
Active Comparator: Multi-arm - FDA cleared NAATs (Comparator); Arm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs)	Diagnostic test: FDA-cleared NAATs; Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Valid results rate	Evaluate indeterminate and unresolved rates	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: NeuMoDx Molecular, Inc.
• Collaborators: NAMSA

Publications and helpful links

Helpful Links

• STD Prevention Conference - Press Release. New CDC analysis shows steep and sustained increases in STDs in recent years. National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
• Chlamydia - CDC Fact Sheet (Detailed). 2016 October 4, [cited 2019 January 3]

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Actual): February 25, 2020
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Sexually Transmitted Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Infections; Communicable Diseases; Chlamydia Infections; Gonorrhea
• Other Study ID Numbers: CTNG-01-18NMD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes