ID NOW™ Test for Chlamydia and Gonorrhea

Overseen By Abinav Singh, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Rapid Dx

Must not be taking: Antimicrobials

Disqualifiers: Recent urination, Prior participation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how effectively the ID NOW™ CT/NG Test detects chlamydia and gonorrhea using urine and swab samples. The goal is to determine if the test performs as well as existing FDA-approved tests. Participants may qualify if they have been sexually active in the past six months and experience symptoms such as unusual discharge or discomfort during urination. As an unphased trial, participation provides an opportunity to contribute to the advancement of diagnostic testing for sexually transmitted infections.

Do I need to stop my current medications to join the trial?

The trial requires that you have not used any antimicrobial therapy (medications that kill or stop the growth of microorganisms) within 14 days before joining. Other medications are not mentioned, so it's best to discuss with the trial team.

What prior data suggests that the ID NOW™ CT/NG Test is safe?

Research has shown that the ID NOW™ CT/NG Test quickly detects infections such as chlamydia and gonorrhea. It provides rapid results. Although detailed safety information for this specific test is unavailable, similar tests are generally easy to handle, requiring only a sample like urine or a swab. No reports indicate problems directly caused by the test itself. This suggests the test is safe for participants, as it does not involve medication or invasive procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ID NOW™ CT/NG Test because it offers a rapid and convenient way to diagnose chlamydia and gonorrhea, conditions traditionally tested using nucleic acid amplification tests (NAATs) that require longer processing times. Unlike standard methods, this test provides results within two hours, potentially speeding up diagnosis and treatment. Additionally, it can be used with self-collected samples, making it easier and more comfortable for patients, while maintaining accuracy and reliability.

What evidence suggests that the ID NOW™ CT/NG Test is effective for detecting chlamydia and gonorrhea?

Research has shown that the ID NOW™ CT/NG test, used by participants in this trial, effectively detects chlamydia and gonorrhea. For chlamydia, the test correctly identifies the infection 96.1% of the time in women and 92.5% of the time in men, meaning it usually detects the infection when present. The test performs as well as other reliable lab tests. These findings suggest that the ID NOW™ test is a strong choice for diagnosing these infections quickly and accurately. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who may have gonorrhea or chlamydia but show no symptoms. Participants will provide samples of male urine, female urine, or self-collected vaginal swabs to be tested.

Inclusion Criteria

The participant and/or legally authorized representative must be willing to undergo the informed consent process prior to study participation

Participants must be able and willing to provide specified samples

I am at least 14 years old in the US or 18 in other countries and can provide vaginal samples and urine.

Exclusion Criteria

Urination within the previous one hour

Previous participation in the study

Inability to meet all inclusion criteria as listed

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection and Testing

Participants provide samples for ID NOW™ CT/NG and comparator assay testing. Samples are collected, handled, stored, shipped, and tested according to the applicable Package Insert(s).

up to 24 months

Multiple visits for sample collection

Data Analysis

The Sponsor performs data analysis to demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA) of the ID NOW™ CT/NG test.

up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after sample collection and testing.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ID NOW™ CT/NG Test

Trial Overview The study aims to evaluate the ID NOW™ CT/NG test's accuracy in detecting gonorrhea and chlamydia using different types of samples. It compares this new test with up to three established tests.

How Is the Trial Designed?

Group I: Experimental: Female/Male collection Experimental Treatment 1 Intervention

Each female participant will provide a 20-50 mL first-catch urine sample, and one (1) self-collected vaginal swab sample and three (3) clinician-collected vaginal swabs. Each male participant will provide a 20-50 mL first-catch urine sample. Each urine sample will be collected in an untreated sterile urine cup. The site staff will test 1.5 ml of urine directly from the specimen cup with ID NOW within two (2) hours of collection. The remaining urine will be aliquoted into applicable transport tubes for each comparator. One (1) self-collected vaginal swab will be collected by the participant in a clinical setting and tested on the device within 2 hours. Three (3) vaginal swabs will be collected by the clinician according to institutional procedures and manufacturer's instructions, one for each of the three (3) NAATs for comparator testing. For comparator tests, the order of CVS sample collection will be randomized.

Who Is Running the Clinical Trial?

Abbott Rapid Dx

Lead Sponsor

Trials

10

Recruited

13,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7225902/

Evaluation of the Performance of a Point-of-Care Test for ... For chlamydia, sensitivity of the new POC assay was 96.1% (95% CI, 91.2%-98.3%) for women and 92.5% (95% CI, 86.4%-96.0%) for men. For gonorrhea ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12484371/

Rapid and simple detection of Chlamydia trachomatis and ... Results. The EasyNAT CT/NG assay demonstrated high concordance with Real-Time PCR, with rates of 98.5% for CT and 99.0% for NG.

3. sciencedirect.com sciencedirect.com/science/article/pii/S152515782030074X

Analytical Evaluation of the Abbott RealTime CT/NG Assay ... These analytical performance data demonstrate that the Abbott CT/NG RealTime assay is an accurate, sensitive, and specific assay in rectal and pharyngeal ...

4. app.trialscreen.org app.trialscreen.org/trials/clinical-evaluation-id-now-ct-ng-test-trial-nct06395675

Clinical Evaluation of the ID NOW™ CT/NG Test This study aims to determine the performance and accuracy of a new rapid test called the ID NOW CT/NG test for detecting Chlamydia trachomatis (CT) and ...

5. ctv.veeva.com ctv.veeva.com/study/clinical-evaluation-of-the-id-now-ct-ng-test

Clinical Evaluation of the ID NOW™ CT/NG Test The objective of this study is to determine the performance of the ID NOW™ CT/NG test in male urine, female urine, and self-collected ...

6. globalpointofcare.abbott globalpointofcare.abbott/us/en/product-details/id-now.html

ID NOW™ Instrument ID NOW™ is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases.

7. fda.gov fda.gov/files/vaccines,%20blood%20&%20biologics/published/Package-Insert-AMPLICOR-CT-NG-Test-for-Chlamydia-trachomatis.pdf

Amplicor CT/NG Test for Chlamydia trachomatis Package ... Material Safety Data Sheets (MSDS) are available on request from your local Roche office. K. Workflow in the laboratory must proceed in a uni-directional ...

8. publichealthontario.ca publichealthontario.ca/en/Laboratory-Services/Test-Information-Index/Chlamydia-trachomatis-NAAT-Swabs

Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Comprehensive instructions for specimen collection, special requirements, specimen handling, testing methods and turnaround times.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9020361/

Diagnostic Tests for Detecting Chlamydia trachomatis and ... This minireview will focus on the current state of diagnostic tests for the detection of rectal and pharyngeal C. trachomatis and N. gonorrhoeae infections.