NCT03970850 - NeuMoDx PrEDiCTiNG Study Evaluation Plan | Biotech Hunter

Enrollment

4,017

Participants

Timeline

Start Date

July 22, 2019

Primary Completion Date

February 25, 2020

Study Completion Date

February 25, 2020

Conditions

Chlamydia Trachomatis InfectionNeisseria Gonorrheae Infection

Interventions

DIAGNOSTIC_TEST

NeuMoDx CT/NG Assay

NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System

DIAGNOSTIC_TEST

FDA-cleared NAATs

Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs

Trial Locations (15)

29425

Medical University of South Carolina (MUSC), Charleston

32817

Planned Parenthood - Southwest and Central Florida, Orlando

33161

Healthcare Clinical Date, Inc. (Segal Trials), North Miami

33617

Planned Parenthood - Southwest and Central Florida, Tampa

35294

University of Alabama, Birmingham

44109

MetroHealth Medical Center, Cleveland

46202

Indiana University (IU), Indianapolis

48108

NeuMoDx Molecular, Inc., Ann Arbor

48202

Henry Ford Health System (HFHS), Detroit

70112

LSU Health Science, New Orleans

77023

Planned Parenthood - Gulf Coast, Houston

87505

TriCore Reference Labs, Albuquerque

07201

Planned Parenthood - Northern, Central and Southern New Jersey, Elizabeth

07860

Planned Parenthood - Northern, Central and Southern New Jersey, Newton

08075

Planned Parenthood - Northern, Central and Southern New Jersey, Riverside Park