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Trial record 11 of 38 for:    Recruiting, Not yet recruiting, Available Studies | Chlamydia

NeuMoDx PrEDiCTiNG Study Evaluation Plan

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ClinicalTrials.gov Identifier: NCT03970850
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
NAMSA
Information provided by (Responsible Party):
NeuMoDx Molecular, Inc.

Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE July 22, 2019
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03970850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
Valid results rate [ Time Frame: Through study completion, an average of 1 year ]
Evaluate indeterminate and unresolved rates
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NeuMoDx PrEDiCTiNG Study Evaluation Plan
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Chlamydia Trachomatis Infection
  • Neisseria Gonorrheae Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Multi-arm - Symptomatic and Asymptomatic Males
    Arm 1 - Urine from males subjects
    Intervention: Diagnostic Test: NeuMoDx CT/NG Assay
  • 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
    Intervention: Diagnostic Test: NeuMoDx CT/NG Assay
  • Active Comparator: Multi-arm - FDA cleared NAATs (Comparator)
    Arm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs)
    Intervention: Diagnostic Test: FDA-cleared NAATs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2019)
3500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2019
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Subjects eligible for CT/NG screening (make sure it matches the protocol)
Ages  ICMJE 14 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nahed Mohsen, PhD 7344770111 nmohsen@neumodx.com
Contact: Sundu Brahmasandra, PhD 7344770111 sundu@neumodx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03970850
Other Study ID Numbers  ICMJE CTNG-01-18NMD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NeuMoDx Molecular, Inc.
Study Sponsor  ICMJE NeuMoDx Molecular, Inc.
Collaborators  ICMJE NAMSA
Investigators  ICMJE Not Provided
PRS Account NeuMoDx Molecular, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP