Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4017 participants
INTERVENTIONAL
2019-07-22
2020-02-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Multi-arm - Symptomatic and Asymptomatic Males
Arm 1 - Urine from males subjects
NeuMoDx CT/NG Assay
NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System
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
NeuMoDx CT/NG Assay
NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System
Multi-arm - FDA cleared NAATs (Comparator)
Arm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs)
FDA-cleared NAATs
Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs
Interventions
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NeuMoDx CT/NG Assay
NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System
FDA-cleared NAATs
Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs
Eligibility Criteria
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Inclusion Criteria
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
2. Subject self-reports use of antibiotics within 28 days of study enrollment.
14 Years
80 Years
ALL
Yes
Sponsors
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NAMSA
OTHER
NeuMoDx Molecular, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama
Birmingham, Alabama, United States
Healthcare Clinical Date, Inc. (Segal Trials)
North Miami, Florida, United States
Planned Parenthood - Southwest and Central Florida
Orlando, Florida, United States
Planned Parenthood - Southwest and Central Florida
Tampa, Florida, United States
Indiana University (IU)
Indianapolis, Indiana, United States
LSU Health Science
New Orleans, Louisiana, United States
NeuMoDx Molecular, Inc.
Ann Arbor, Michigan, United States
Henry Ford Health System (HFHS)
Detroit, Michigan, United States
Planned Parenthood - Northern, Central and Southern New Jersey
Elizabeth, New Jersey, United States
Planned Parenthood - Northern, Central and Southern New Jersey
Newton, New Jersey, United States
Planned Parenthood - Northern, Central and Southern New Jersey
Riverside Park, New Jersey, United States
TriCore Reference Labs
Albuquerque, New Mexico, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Planned Parenthood - Gulf Coast
Houston, Texas, United States
Countries
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Other Identifiers
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CTNG-01-18NMD
Identifier Type: -
Identifier Source: org_study_id
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