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NeuMoDx PrEDiCTiNG Study Evaluation Plan

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gonorrhea

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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970850


Locations
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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
Additional Information:
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Responsible Party: NeuMoDx Molecular, Inc.
ClinicalTrials.gov Identifier: NCT03970850    
Other Study ID Numbers: CTNG-01-18NMD
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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