NeuMoDx PrEDiCTiNG Study Evaluation Plan NCT03970850

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT03970850
Other study ID #	CTNG-01-18NMD
Secondary ID
Status	Completed
Phase	N/A
First received
Last updated
Start date	July 22, 2019
Est. completion date	February 25, 2020

Study information
Verified date	June 2020
Source	NeuMoDx Molecular, Inc.
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status	Completed
Enrollment	4017
Est. completion date	February 25, 2020
Est. primary completion date	February 25, 2020
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	14 Years to 80 Years
Eligibility	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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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

Locations
Country	Name	City	State
United States	TriCore Reference Labs	Albuquerque	New Mexico
United States	NeuMoDx Molecular, Inc.	Ann Arbor	Michigan
United States	University of Alabama	Birmingham	Alabama
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Planned Parenthood - Northern, Central and Southern New Jersey	Delran	New Jersey
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 - Gulf Coast	Houston	Texas
United States	Indiana University (IU)	Indianapolis	Indiana
United States	LSU Health Science	New Orleans	Louisiana
United States	Planned Parenthood - Northern, Central and Southern New Jersey	Newton	New Jersey
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

Sponsors *(2)*
Lead Sponsor	Collaborator
NeuMoDx Molecular, Inc.	NAMSA

Country where clinical trial is conducted

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	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)	Through study completion, an average of 1 year
Secondary	Valid results rate	Evaluate indeterminate and unresolved rates	Through study completion, an average of 1 year

See also
Status	Clinical Trial	Phase
Completed	`NCT04269434` - GonoScreen: Efficacy of Screening STIs in MSM	N/A
Active, not recruiting	`NCT04139629` - Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and ART Outcomes in Women With TFI	N/A
Completed	`NCT03107377` - Phase 2B/3 Double-blinded Placebo-controlled	Phase 2/Phase 3
Completed	`NCT03098329` - Check it: A New Approach to Controlling Chlamydia Transmission in Young People	N/A
Recruiting	`NCT03862495` - Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT	N/A
Completed	`NCT05307991` - Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe
Terminated	`NCT02083276` - Mecillinam for Treatment of Genital Chlamydia Infection	Phase 2
Active, not recruiting	`NCT06131749` - Genital Tract Infections, the Vaginal Microbiome and Gestational Age at Birth Among Pregnant Women in South Africa
Completed	`NCT03568695` - Detection of Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium by Real-time Multiplex Polymerase Chain Reaction (PCR) After Pooling Pharyngeal, Anorectal and Urinary Samples	N/A
Completed	`NCT01448876` - Incubation Time and Test of Cure of Chlamydia Trachomatis	N/A
Not yet recruiting	`NCT06369220` - A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections	N/A
Not yet recruiting	`NCT06395675` - Clinical Evaluation of the ID NOW™ CT/NG Test	N/A
Completed	`NCT01631201` - Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women	Phase 2
Completed	`NCT05216744` - Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection	Phase 2
Recruiting	`NCT05581160` - Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST)	N/A
Not yet recruiting	`NCT03532464` - Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection	Phase 4
Not yet recruiting	`NCT06234943` - Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia	N/A
Active, not recruiting	`NCT04050540` - Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP	Phase 4
Completed	`NCT04955717` - Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences	N/A
Active, not recruiting	`NCT05666778` - Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs	Phase 2

NeuMoDx PrEDiCTiNG Study Evaluation Plan

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (2)

Country where clinical trial is conducted

Outcome

External Links