NeuMoDx PrEDiCTiNG Study Evaluation Plan

• ClinicalTrials.gov Identifier: NCT03970850
• Recruitment Status: Completed
• First Posted: June 3, 2019
• Last Update Posted: June 12, 2020
• Sponsor: NeuMoDx Molecular, Inc.
• Collaborator: NAMSA
• Information provided by (Responsible Party): NeuMoDx Molecular, Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Chlamydia Trachomatis Infection; Neisseria Gonorrheae Infection	Diagnostic Test: NeuMoDx CT/NG Assay; Diagnostic Test: FDA-cleared NAATs	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4017 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official 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
• Actual Study Start Date: July 22, 2019
• Actual Primary Completion Date: February 25, 2020
• Actual Study Completion Date: February 25, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Valid results rate [ Time Frame: Through study completion, an average of 1 year ]
   Evaluate indeterminate and unresolved rates

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Subjects eligible for CT/NG screening (make sure it matches the protocol)
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama

Birmingham, Alabama, United States, 35294

United States, Florida

Healthcare Clinical Date, Inc. (Segal Trials)

North Miami, Florida, United States, 33161

Planned Parenthood - Southwest and Central Florida

Orlando, Florida, United States, 32817

Planned Parenthood - Southwest and Central Florida

Tampa, Florida, United States, 33617

United States, Indiana

Indiana University (IU)

Indianapolis, Indiana, United States, 46202

United States, Louisiana

LSU Health Science

New Orleans, Louisiana, United States, 70112

United States, Michigan

NeuMoDx Molecular, Inc.

Ann Arbor, Michigan, United States, 48108

Henry Ford Health System (HFHS)

Detroit, Michigan, United States, 48202

United States, New Jersey

Planned Parenthood - Northern, Central and Southern 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

United States, New Mexico

TriCore Reference Labs

Albuquerque, New Mexico, United States, 87505

United States, Ohio

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

United States, South Carolina

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States, 29425

United States, Texas

Planned Parenthood - Gulf Coast

Houston, Texas, United States, 77023

Sponsors and Collaborators

NeuMoDx Molecular, Inc.

NAMSA

More Information

Additional Information:

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 

Sexually Transmitted Diseases Treatment Guidelines, 2015. Centers for Disease Control and Prevention MMWR. 2015 June 5 Vol. 64. No. 3. 

Chlamydia - CDC Fact Sheet (Detailed). 2016 October 4, [cited 2019 January 3] 

• Responsible Party: NeuMoDx Molecular, Inc.
• ClinicalTrials.gov Identifier: NCT03970850
• Other Study ID Numbers: CTNG-01-18NMD
• First Posted: June 3, 2019
• Last Update Posted: June 12, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Infection; Communicable Diseases; Chlamydia Infections; Gonorrhea; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Neisseriaceae Infections