Topics

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

2016-08-19 11:25:22 | BioPortfolio

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.

Description

Background & Significance: Infections due to Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) are major threats to public health. In 2008, the World Health Organization (WHO) estimated more than 100 million new worldwide cases for each of NG and CT. In 2013, there were 333,000 NG and 1.4 million CT genitourinary infections in the US. Most CT and NG infections are asymptomatic, but infection can lead to serious sequelae, including infertility, chronic pelvic pain, adverse obstetrical outcomes, increased risk of acquiring the human immunodeficiency virus (HIV), and disseminated infection.

There has also been growing concern over antibiotic resistance. In 2013, the US Centers for Disease Control and Prevention (CDC) classified drug-resistant NG as one of the three urgent-level resistant bacteria. Improved detection of extragenital NG is thought to be a crucial component of adequate treatment and for prevention of further resistance.

Currently, the CDC recommends using NAATs to screen and diagnose for NG and CT in the genitourinary tract due to their superior sensitivity compared to traditional culture methods. The sensitivity and specificity of commercially available NAATs for the detection of urogenital NG and CT is estimated to be between 90-100%. The CDC also recommends using NAATs for screening and diagnosis of NG and CT in extragenital sites. Due to widespread use and interest in these tests for extragenital NG and CT infections, multiple studies have examined the test characteristics of NAAT tests in comparison to culture and to additional NAAT platforms. For diagnosis of CT, reported sensitivities are 80-100% (pharyngeal) and 46-100% (rectal), with significant variation by platform tested. Reported specificities are >99% for pharyngeal site and 89-100% for the rectum. For diagnosis of NG, reported sensitivities are 72-100% (pharyngeal) and 75-100% (rectal), again with variation by platform. Reported specificities are 72-100% (pharyngeal) and 95-100% (rectal).

Despite the CDC's recommendations, however, there are currently no FDA-approved commercial NAAT tests for the detection of pharyngeal and rectal NG or CT infections. The FDA's clearance of such assays would increase the ability to diagnose and control NG and CT extragenital infections. This research study will help provide the data required for FDA consideration to clear such assays for marketing.

Design & Procedures: This will be a cross-sectional, single visit study evaluating the performance of three commercial NAATs to detect NG and CT in the rectum and pharynx. A fourth NAAT is being used as a tiebreaker. The performance of the fourth NAAT will not be evaluated. Each manufacturer will provide a specific collection kit and transport media.

This research study will take place at healthcare clinics which focus on sexually transmitted diseases, women's health, student health, family planning clinics, and clinics specializing in lesbian, gay, bisexual, and transgender (LGBT) health. This research will include specimens collected from 2,500 adult males, females, and transgender persons who are seeking sexually transmitted disease (STD) testing at the participating study clinics. Both symptomatic and asymptomatic subjects will be included in the study population.

Potential subjects will be identified, assessed for eligibility, and asked to provide oral informed consent. If they agree to take part in the research, study subjects will have eight swabs collected: four pharyngeal and four rectal. The swabs needed for routine clinical care will be taken first. All study procedures will take place during one clinic visit. There will not be a follow-up visit as part of this study. Subjects will continue with routine clinical care as directed by their medical providers.

Subject participation will be confidential and anonymous. The results of the tests and subject participant in this research will not be placed in the subjects' medical records.

Each study swab will be used for a specific NAAT, which will be run at one of the two reference testing laboratories. The Anatomic Site Infection Status (ASIS) will be defined by the results of the two other NAATs, and, if necessary, a tiebreaker test. Each anatomic site will be considered in isolation. If fewer than four swabs at a site are completed, that anatomic site (and swab results) will be excluded from the analysis.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Neisseria Gonorrhoeae Infection

Intervention

NAAT 1 to Detect Rectal and Pharyngeal NG and CT, NAAT 2 to Detect Rectal and Pharyngeal NG and CT, NAAT 3 to Detect Rectal and Pharyngeal NG and CT, NAAT 4 to Detect Rectal and Pharyngeal NG, NAAT 4 to Detect Rectal and Pharyngeal CT

Status

Not yet recruiting

Source

Duke University

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-08-19T11:25:22-0400

Clinical Trials [2579 Associated Clinical Trials listed on BioPortfolio]

Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal pharmacokinetics of a single 1000mg oral dose of solithromycin. Study Objectives: The primary objective...

TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment

The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid ampli...

Randomized, Double-Blinded, Placebo-Controlled Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM

A Phase 4 trial to compare the efficacy of azithromycin (Arm 1) vs. doxycycline (Arm 2) administered per CDC's STD Treatment Guidelines for rectal Chlamydia trachomatis (CT) in men who hav...

Simultaneous Fluoroscopic and Manometric Measures of the Oropharyngeal Phase of Deglutition

To validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry.

PET/CT for Staging Rectal Cancer Patients With and Without EMVI-MR

The hypothesis to be proven with this study is that the use of PET/CT on the initial staging of rectal cancers in patients with extramural vascular invasion detected by MR will detect more...

PubMed Articles [3404 Associated PubMed Articles listed on BioPortfolio]

Simultaneous Evaluation of Diagnostic Assays for Pharyngeal and Rectal Neisseria gonorrhoeae and Chlamydia trachomatis Using a Master Protocol.

Pharyngeal and rectal Neisseriagonorrhoeae and Chlamydiatrachomatis play important roles in infection and antibacterial resistance transmission, but no Food and Drug Administration-cleared assays for ...

Comparison of 3 Nucleic Acid Amplification Tests and a Rapid Antigen Test with Culture for the Detection of Group A Streptococci from Throat Swabs.

Recently, the US Food and Drug Administration cleared 3 nucleic acid amplification test (NAAT) assays for detection of [group A (GAS)] in pharyngeal specimens. However, there are limited studies eva...

Gentamicin 240 mg plus azithromycin 2 g vs. ceftriaxone 500 mg plus azithromycin 2 g for treatment of rectal and pharyngeal gonorrhoea: a randomized controlled trial.

To evaluate the efficacy and tolerability of gentamicin 240 mg plus azithromycin 2 g for treatment of uncomplicated rectal and pharyngeal gonorrhoea compared to ceftriaxone 500 mg plus azithromycin 2 ...

High burden of chlamydia and gonorrhoea in pharyngeal, rectal and urethral sites among Thai transgender women: implications for anatomical site selection for the screening of STI.

Comprehensive data on (CT) and (NG) infections to guide screening services among transgender women (TGW) are limited. We studied the burden of CT/NG infections in pharyngeal, rectal and urethral sit...

FEES-based assessment of pharyngeal hypesthesia-Proposal and validation of a new test procedure.

Intact pharyngeal sensation is essential for a physiological swallowing process, and conversely, pharyngeal hypesthesia can cause dysphagia. This study introduces and validates a diagnostic test to qu...

Medical and Biotech [MESH] Definitions

The ability to detect sharp boundaries (stimuli) and to detect slight changes in luminance at regions without distinct contours. Psychophysical measurements of this visual function are used to evaluate visual acuity and to detect eye disease.

A deep blue dye (with the formula OC6H4NC6H4OH) used to detect AMMONIA in a common test called the Berthelot's reaction and to detect PARACETAMOL by spectrophotometry.

A diverticulum from the fourth pharyngeal pouch of an embryo, regarded by some as a rudimentary fifth pharyngeal pouch and by others as a lateral thyroid primordium. The ultimobranchial bodies of lower vertebrates contain large amounts of calcitonin. In mammals the bodies fuse with the thyroid gland and are thought to develop into the parafollicular cells. (Stedman, 25th ed)

A test to detect non-agglutinating ANTIBODIES against ERYTHROCYTES by use of anti-antibodies (the Coombs' reagent.) The direct test is applied to freshly drawn blood to detect antibody bound to circulating red cells. The indirect test is applied to serum to detect the presence of antibodies that can bind to red blood cells.

The muscles of the PHARYNX are voluntary muscles arranged in two layers. The external circular layer consists of three constrictors (superior, middle, and inferior). The internal longitudinal layer consists of the palatopharyngeus, the salpingopharyngeus, and the stylopharyngeus. During swallowing, the outer layer constricts the pharyngeal wall and the inner layer elevates pharynx and LARYNX.

More From BioPortfolio on "Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT"

Quick Search

Relevant Topics

Sexual Health
The World Health Organization (WHO) definition of sexual health; "the state of physical, emotional, mental and social well-being related to sexuality; it is not merely the absence of disease, dysfunction and infirmity. Sexual health requires a posit...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...


Searches Linking to this Trial