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NeuMoDx PrEDiCTiNG Study Evaluation Plan

Primary Purpose

Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeuMoDx CT/NG Assay
FDA-cleared NAATs
Sponsored by
NeuMoDx Molecular, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chlamydia Trachomatis Infection

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama
  • Healthcare Clinical Date, Inc. (Segal Trials)
  • Planned Parenthood - Southwest and Central Florida
  • Planned Parenthood - Southwest and Central Florida
  • Indiana University (IU)
  • LSU Health Science
  • NeuMoDx Molecular, Inc.
  • Henry Ford Health System (HFHS)
  • Planned Parenthood - Northern, Central and Southern New Jersey
  • Planned Parenthood - Northern, Central and Southern New Jersey
  • Planned Parenthood - Northern, Central and Southern New Jersey
  • TriCore Reference Labs
  • MetroHealth Medical Center
  • Medical University of South Carolina (MUSC)
  • Planned Parenthood - Gulf Coast

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Multi-arm - Symptomatic and Asymptomatic Males

Multi-arm - Symptomatic and Asymptomatic Females

Multi-arm - FDA cleared NAATs (Comparator)

Arm Description

Arm 1 - Urine from males subjects

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Valid results rate
Evaluate indeterminate and unresolved rates

Full Information

First Posted
May 30, 2019
Last Updated
June 11, 2020
Sponsor
NeuMoDx Molecular, Inc.
Collaborators
NAMSA
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1. Study Identification

Unique Protocol Identification Number
NCT03970850
Brief Title
NeuMoDx PrEDiCTiNG Study Evaluation Plan
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuMoDx Molecular, Inc.
Collaborators
NAMSA

4. Oversight

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
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4017 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-arm - Symptomatic and Asymptomatic Males
Arm Type
Active Comparator
Arm Description
Arm 1 - Urine from males subjects
Arm Title
Multi-arm - Symptomatic and Asymptomatic Females
Arm Type
Active Comparator
Arm Description
Arm 2 - Endocervical, self-collected (in the clinical setting) and physician-collected vaginal swabs and urine from female subjects
Arm Title
Multi-arm - FDA cleared NAATs (Comparator)
Arm Type
Active Comparator
Arm Description
Arm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs)
Intervention Type
Diagnostic Test
Intervention Name(s)
NeuMoDx CT/NG Assay
Intervention Description
NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System
Intervention Type
Diagnostic Test
Intervention Name(s)
FDA-cleared NAATs
Intervention Description
Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs
Primary Outcome Measure Information:
Title
Clinical specificity and sensitivity
Description
Clinical specificity and sensitivity of NeuMoDx CT/NG Assay for both CT and NG relative to an individual's patient infected status (PIS)
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Valid results rate
Description
Evaluate indeterminate and unresolved rates
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Subjects eligible for CT/NG screening (make sure it matches the protocol)
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Healthcare Clinical Date, Inc. (Segal Trials)
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Planned Parenthood - Southwest and Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32817
Country
United States
Facility Name
Planned Parenthood - Southwest and Central Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Indiana University (IU)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
LSU Health Science
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
NeuMoDx Molecular, Inc.
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Henry Ford Health System (HFHS)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Planned Parenthood - Northern, Central and Southern New Jersey
City
Delran
State/Province
New Jersey
ZIP/Postal Code
08075
Country
United States
Facility Name
Planned Parenthood - Northern, Central and Southern New Jersey
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07201
Country
United States
Facility Name
Planned Parenthood - Northern, Central and Southern New Jersey
City
Newton
State/Province
New Jersey
ZIP/Postal Code
07860
Country
United States
Facility Name
TriCore Reference Labs
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Planned Parenthood - Gulf Coast
City
Houston
State/Province
Texas
ZIP/Postal Code
77023
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.cdc.gov/nchhstp/newsroom/2018/press-release-2018-std-prevention-conference.html
Description
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
URL
https://www.cdc.gov/std/chlamydia/stdfact-chlamydia-detailed.htm
Description
Chlamydia - CDC Fact Sheet (Detailed). 2016 October 4, [cited 2019 January 3]

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NeuMoDx PrEDiCTiNG Study Evaluation Plan

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