NeuMoDx PrEDiCTiNG Study Evaluation Plan

NeuMoDx molecular

Status: Completed

Conditions: Chlamydia Trachomatis Infection; Neisseria Gonorrheae Infection

Treatments: Diagnostic Test: FDA-cleared NAATs; Diagnostic Test: NeuMoDx CT/NG Assay

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03970850

CTNG-01-18NMD

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4,017 patients

Sex: All

Ages: 14 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,017 participants in 3 patient groups

Multi-arm - Symptomatic and Asymptomatic Males

Active Comparator group

Description:

Arm 1 - Urine from males subjects

Treatment:

Diagnostic Test: NeuMoDx CT/NG Assay

Multi-arm - Symptomatic and Asymptomatic Females

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: NeuMoDx CT/NG Assay

Multi-arm - FDA cleared NAATs (Comparator)

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: FDA-cleared NAATs