NeuMoDx PrEDiCTiNG Study Evaluation Plan
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03970850 |
Recruitment Status :
Completed
First Posted : June 3, 2019
Last Update Posted : June 12, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 (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 |
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 |
- 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)
- Valid results rate [ Time Frame: Through study completion, an average of 1 year ]Evaluate indeterminate and unresolved rates

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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.

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