Clinical trial NCT03970850: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydia Trachomatis Infection
Neisseria Gonorrheae Infection
Lead sponsor: NeuMoDx Molecular, Inc.
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2019-06-03
Enrollment: 4017
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical specificity and sensitivity
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Valid results rate
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: North Miami
country: United States
facility: Healthcare Clinical Date, Inc. (Segal Trials)
state: Florida
city: Orlando
country: United States
facility: Planned Parenthood - Southwest and Central Florida
state: Florida
city: Tampa
country: United States
facility: Planned Parenthood - Southwest and Central Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana University (IU)
state: Indiana
city: New Orleans
country: United States
facility: LSU Health Science
state: Louisiana
city: Ann Arbor
country: United States
facility: NeuMoDx Molecular, Inc.
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System (HFHS)
state: Michigan
city: Delran
country: United States
facility: Planned Parenthood - Northern, Central and Southern New Jersey
state: New Jersey
city: Elizabeth
country: United States
facility: Planned Parenthood - Northern, Central and Southern New Jersey
state: New Jersey
city: Newton
country: United States
facility: Planned Parenthood - Northern, Central and Southern New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: TriCore Reference Labs
state: New Mexico
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Houston
country: United States
facility: Planned Parenthood - Gulf Coast
state: Texas
Study officials:
References: