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Trial record 3 of 81 for:    chlamydia trachomatis | "Sexually Transmitted Diseases"

Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT (pNAAT)

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ClinicalTrials.gov Identifier: NCT02870101
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to provide data and analyses to support 510(k) applications to the FDA for multiple nucleic acid amplification tests (NAATs) diagnostic platforms.

Condition or disease Intervention/treatment Phase
Neisseria Gonorrhoeae Infection Chlamydia Trachomatis Infection Sexually Transmitted Diseases Device: NAAT 1 to Detect Rectal and Pharyngeal NG and CT Device: NAAT 2 to Detect Rectal and Pharyngeal NG and CT Device: NAAT 3 to Detect Rectal and Pharyngeal NG and CT Device: NAAT 4 to Detect Rectal and Pharyngeal NG Device: NAAT 4 to Detect Rectal and Pharyngeal CT Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2767 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: All information collected anonymously.
Primary Purpose: Other
Official Title: Performance of Nucleic Acid Amplification Tests for the Detection of Neisseria Gonorrhoeae and Chlamydia Trachomatis in Extragenital Sites
Actual Study Start Date : April 10, 2017
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : March 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NAAT 1 to Detect Rectal NG and CT
Performance of nucleic acid amplification test assay number 1, estimating the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis from a rectal swab.
Device: NAAT 1 to Detect Rectal and Pharyngeal NG and CT
Nucleic acid amplification assay test 1 to estimate the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis in the rectum and pharynx.
Other Name: Nucleic Acid Amplification Test 1

Active Comparator: NAAT 1 to Detect Pharyngeal NG and CT
Performance of nucleic acid amplification test assay number 1, estimating the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis from a pharyngeal swab.
Device: NAAT 1 to Detect Rectal and Pharyngeal NG and CT
Nucleic acid amplification assay test 1 to estimate the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis in the rectum and pharynx.
Other Name: Nucleic Acid Amplification Test 1

Active Comparator: NAAT 2 to Detect Rectal NG and CT
Performance of nucleic acid amplification test assay number 2, estimating the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis from a rectal swab.
Device: NAAT 2 to Detect Rectal and Pharyngeal NG and CT
Nucleic acid amplification assay test 2 to estimate the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis in the rectum and pharynx.
Other Name: Nucleic Acid Amplification Test 2

Active Comparator: NAAT 2 to Detect Pharyngeal NG and CT
Performance of nucleic acid amplification test assay number 2, estimating the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis from a pharyngeal swab.
Device: NAAT 2 to Detect Rectal and Pharyngeal NG and CT
Nucleic acid amplification assay test 2 to estimate the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis in the rectum and pharynx.
Other Name: Nucleic Acid Amplification Test 2

Active Comparator: NAAT 3 to Detect Rectal NG and CT
Performance of nucleic acid amplification test assay number 3, estimating the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis from a rectal swab.
Device: NAAT 3 to Detect Rectal and Pharyngeal NG and CT
Nucleic acid amplification assay test 3 to estimate the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis in the pharynx and rectum.
Other Name: Nucleic Acid Amplification Test 3

Active Comparator: NAAT 3 to Detect Pharyngeal NG and CT
Performance of nucleic acid amplification test assay number 3, estimating the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis from a pharyngeal swab.
Device: NAAT 3 to Detect Rectal and Pharyngeal NG and CT
Nucleic acid amplification assay test 3 to estimate the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae and Chlamydia trachomatis in the pharynx and rectum.
Other Name: Nucleic Acid Amplification Test 3

Active Comparator: NAAT 4 to Detect Rectal and Pharyngeal NG
Performance of nucleic acid amplification test assay number 4, estimating the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae from rectal and pharyngeal swabs. To be used as a tiebreaker if reference tests disagree.
Device: NAAT 4 to Detect Rectal and Pharyngeal NG
Nucleic acid amplification assay test 4 to estimate the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Neisseria gonorrhoeae in the rectum and pharynx. Test 4 will be used as a tiebreaker assay in case of disagreement between the reference NAAT results.
Other Name: Nucleic Acid Amplification Test 4

Active Comparator: NAAT 4 to Detect Rectal and Pharyngeal CT
Performance of nucleic acid amplification test assay number 4, estimating the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Chlamydia trachomatis from rectal and pharyngeal swabs. To be used as a tiebreaker if reference tests disagree.
Device: NAAT 4 to Detect Rectal and Pharyngeal CT
Nucleic acid amplification assay test 4 to estimate the positive percent agreement (PPA) and negative percent agreement (NPA) for detecting Chlamydia trachomatis in the rectum and pharynx. Test 4 will be used as a tiebreaker assay in case of disagreement between the reference NAAT results.
Other Name: Nucleic Acid Amplification Test 4




Primary Outcome Measures :
  1. Anatomic Site Infected Status (ASIS) for each anatomic site and each organism [ Time Frame: 1 day ]
    For each NAAT, the ASIS will be determined for each anatomic site (pharyngeal and rectal) and each organism (NG and CT).


Secondary Outcome Measures :
  1. Anatomic Site Infected Status (ASIS) by sex [ Time Frame: 1 day ]
    For each NAAT, the anatomic site infected status (ASIS) will be determined for each anatomic site (pharyngeal and rectal) and each organism (NG and CT) by sex .

  2. Anatomic Site Infected Status (ASIS) by symptom status [ Time Frame: 1 day ]
    For each NAAT, the anatomic site infected status (ASIS) will be determined for each anatomic site (pharyngeal and rectal) and each organism (NG and CT) by symptom status.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Attending a participating clinic for evaluation of STIs
  2. ≥18 years of age at date of screening
  3. Able and willing to provide informed consent
  4. Willing to comply with study procedures, including collection of 4 swabs each from the pharynx and rectum for NG and CT testing

Exclusion Criteria:

  1. Receipt of any systemic antibacterial drug in the past 14 days
  2. Receipt of myelosuppressive chemotherapy in the past 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870101


Locations
United States, California
AIDS Health Foundation - Hollywood
Hollywood, California, United States, 90028
Los Angeles LGBT Clinic
Los Angeles, California, United States, 90028
United States, Florida
AIDS Healthcare Foundation - Miami
Miami, Florida, United States, 33133
University of Miami
Miami, Florida, United States, 33136
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
Sponsors and Collaborators
Duke University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Jeffrey D Klausner, MD, MPH UCLA David Geffen School of Medicine and Fielding School of Public Health

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02870101     History of Changes
Other Study ID Numbers: Pro00073558
5UM1AI104681 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Duke University:
Nucleic acid amplification tests
Neisseria gonorrhoeae infection
Chlamydia trachomatis infection
Sexually transmitted diseases
Pharynx
Rectum
Gram-Negative Bacterial Infections
Bacterial Infections
Genital Diseases, Male
Genital Diseases, Female

Additional relevant MeSH terms:
Chlamydia Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Infection
Communicable Diseases
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Genital Diseases, Male
Genital Diseases, Female
Virus Diseases
Neisseriaceae Infections