New Test for Sexually Transmitted Infections

No longer recruiting at 4 trial locations

Overseen By Babar Javed, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hoffmann-La Roche

Must not be taking: Macrolides, Penicillins, Tetracyclines, others

Disqualifiers: Pregnancy, Routine screening, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new rapid test, the cobas® liat CT/NG/MG, to determine if it surpasses current methods for diagnosing certain sexually transmitted infections (STIs), such as Chlamydia, Gonorrhea, and Mycoplasma Genitalium. The study includes two groups: one using standard testing methods and the other using the new test. Sexually active individuals with STI symptoms or known exposure may be suitable participants. The goal is to determine if the new test can enable doctors to make faster and more accurate treatment decisions. As an unphased trial, this study offers participants the opportunity to contribute to potentially groundbreaking diagnostic advancements.

Will I have to stop taking my current medications?

If you are taking antibiotics for Chlamydia, Gonorrhea, or Mycoplasma infections, or certain urinary pain relief medicines, you will need to stop them before joining the trial. Specifically, you should not have used these antibiotics in the 21 days before the trial or urinary pain relief medicines in the 2 days before the trial.

What prior data suggests that the cobas® liat CT/NG/MG Test is safe for diagnosing urogenital infections?

Research has shown that the cobas® liat CT/NG/MG test detects infections such as chlamydia, gonorrhea, and Mycoplasma genitalium. This test enables doctors to quickly identify these infections, leading to faster and more accurate treatment decisions.

The test itself poses no specific safety concerns because it is a non-invasive diagnostic tool, not a medication or treatment. Therefore, it does not cause side effects like those associated with drugs. The process involves collecting a sample, usually with a swab, to check for these infections.

In summary, the cobas® liat CT/NG/MG test is well-tolerated because it diagnoses infections rather than treats them, making it a safe option for anyone considering participation in a clinical trial involving this test. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cobas® liat CT/NG/MG test because it offers a quick and efficient way to diagnose sexually transmitted infections like chlamydia, gonorrhea, and Mycoplasma genitalium right at the point of care. Unlike traditional lab tests, which can take days to return results, this test can deliver accurate results in a matter of minutes, allowing for immediate clinical decisions. This rapid turnaround time can improve patient management, reduce the spread of infections, and enhance the overall efficiency of healthcare delivery.

What evidence suggests that the cobas® liat CT/NG/MG Test is effective for diagnosing urogenital infections?

Research has shown that the cobas® liat CT/NG/MG test, used by participants in the Point of Care (POC) arm of this trial, effectively detects infections caused by Chlamydia, Gonorrhea, and Mycoplasma genitalium. This test employs real-time PCR, a highly accurate method for identifying these infections. Studies indicate that this test enables quicker and more precise diagnoses, allowing doctors to select the best treatment faster, improving patient health, and reducing unnecessary treatments. ^{1 3 4 6 7}

Who Is on the Research Team?

Zune Huynh, MD

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for sexually active individuals seeking medical attention for symptoms that suggest a sexually transmitted infection (STI) or those who know they've been exposed to an STI.

Inclusion Criteria

I am sexually active.

I am seeking treatment for symptoms or exposure to an STI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are evaluated and managed based on either standard practice or point of care test results

1 day

1 visit (in-person)

Follow-up

Participants' satisfaction and confidence in the testing procedures are assessed

4 months

Bi-weekly assessments

What Are the Treatments Tested in This Trial?

Interventions

• cobas® liat CT/NG/MG Test

Trial Overview The study compares the cobas® liat CT/NG/MG test, which quickly detects Chlamydia, Gonorrhea, and Mycoplasma Genitalium at the point of care, against the usual diagnostic practices by clinicians.

How Is the Trial Designed?

Group I: Standard of Care (SOC) Arm: Standard Practice Experimental Treatment 1 Intervention

In the SOC arm, the clinician will evaluate the participant based on standard practice.

Group II: Point of Care (POC) Arm: cobas® liat CT/NG/MG Experimental Treatment 1 Intervention

In the POC arm, the clinician will evaluate the participant and will be provided POC test results upon which they may choose to base their clinical decisions.

cobas® liat CT/NG/MG Test is already approved in United States, European Union for the following indications:

Approved in United States as cobas CT/NG/MG Test for:

• Diagnosis of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) infections

Approved in European Union as cobas CT/NG/MG Test for:

• Diagnosis of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) infections

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Roche Molecular Systems, Inc

Industry Sponsor

Trials

5

Recruited

9,600+

Published Research Related to This Trial

The Roche cobas® CT/NG test (c4800) demonstrated excellent sensitivity (97.6%) and specificity (99.5%) for detecting Chlamydia trachomatis in male urine, and 100% sensitivity and 99.7% specificity for Neisseria gonorrhoeae, based on a study involving 790 men.

The performance of the c4800 assay was consistent across both symptomatic and asymptomatic participants, indicating its reliability as a diagnostic tool comparable to existing nucleic acid amplification tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Roche cobas® CT/NG test for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in male urine. Taylor, SN., Liesenfeld, O., Lillis, RA., et al.[2019]

The Roche cobas CT/NG assay, used on the cobas 6800/8800 system, offers high throughput and efficiency for testing Chlamydia trachomatis and Neisseria gonorrhoeae, which is crucial given the rising infection rates worldwide.

This diagnostic tool not only provides high sensitivity and specificity but also integrates well with other lab systems, enhancing overall laboratory efficiency and allowing for the expansion of testing capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A profile of the cobas® CT/NG assay on the cobas® 6800/8800 system for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Van Der Pol, B.[2021]

The Roche cobas 4800 CT/NG assay is highly sensitive and specific for detecting Neisseria gonorrhoeae in urogenital samples, but this study reports the first confirmed clinical false-positive result from a pharyngeal swab.

The false-positive was attributed to cross-reaction with a non-pathogenic Neisseria strain, highlighting the need for careful interpretation of results, especially in non-urogenital samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neisseria gonorrhoeae false-positive result obtained from a pharyngeal swab by using the Roche cobas 4800 CT/NG assay in New Zealand in 2012. Upton, A., Bromhead, C., Whiley, DM.[2021]

The Cobas® CT/NG test on the Cobas® 6800/8800 Systems demonstrated high analytical sensitivity for detecting Chlamydia trachomatis and Neisseria gonorrhoeae, with an overall agreement of over 98.5% compared to the Cobas® 4800 CT/NG Test across more than 12,000 specimens.

This new testing system provides a reliable and efficient automated solution for STI screening, confirming a significant number of previously discordant results through sequencing, particularly in extragenital specimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Throughput Testing of Urogenital and Extragenital Specimens for Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae with Cobas® CT/NG. Marlowe, EM., Hardy, D., Krevolin, M., et al.[2020]

The cobas CT/NG v2.0 test demonstrated high sensitivity (up to 98.4% for men and 97.6% for women) and specificity (up to 99.7%) for detecting Chlamydia trachomatis and Neisseria gonorrhoeae infections in a study of 6004 participants, including both symptomatic and asymptomatic individuals.

This test effectively identifies infections using various specimen types, including urogenital swabs and urine, making it a reliable tool for combating these common sexually transmitted infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of Chlamydia trachomatis and Neisseria gonorrhoeae with the cobas CT/NG v2.0 test: performance compared with the BD ProbeTec CT Qx and GC Qx amplified DNA and Aptima AC2 assays. Nye, MB., Osiecki, J., Lewinski, M., et al.[2020]

The cobas 4800 CT/NG assay is a highly effective diagnostic tool for detecting Chlamydia trachomatis and Neisseria gonorrhoeae, with excellent sensitivity and specificity due to its dual primer targets.

This assay allows for self-obtained sample types, making it user-friendly and accessible, which is crucial for controlling the spread of these common sexually transmitted infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cobas® 4800: a fully automated system for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Van Der Pol, B.[2013]

Citations

1. diagnostics.roche.com diagnostics.roche.com/us/en/products/lab/cobas-liat-ct-ng-mg-pid00000922.html

cobas® liat CT/NG/MG, nucleic acid test The cobas® liat CT/NG/MG assay provides differential results for chlamydia, gonorrhea and Mycoplasma genitalium to inform treatment decisions.

2. journals.asm.org journals.asm.org/doi/10.1128/jcm.00706-25

Sensitivity and specificity of the Cobas Liat CT/NG/MG nucleic ... Use of the Cobas Liat CT/NG/MG assay may also result in improved patient outcomes, help realize population benefits by reducing the duration of ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/K240197.pdf

A 510(k) Number K240197 B Applicant Roch The cobas liat CT/NG/MG nucleic acid test is an automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction ( ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41159798/

Sensitivity and specificity of the Cobas Liat CT/NG/MG ... POC testing can facilitate rapid pathogen identification and accurate treatment, thereby mitigating the need for empiric treatment.

5. ctv.veeva.com ctv.veeva.com/study/a-study-of-the-cobas-r-liat-ct-ng-mg-test-versus-current-standard-practice-for-managing-participants

A Study of the Cobas® Liat CT/NG/MG Test Versus Current ... This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and ...

6. diagnostics.roche.com diagnostics.roche.com/content/dam/diagnostics/us/en/products/c/cobas-liat-support/ct-ng-mg-ifu.pdf

cobas® liat CT/NG/MG nucleic acid test If left untreated, infections caused by CT, NG, and. MG can cause complications in the uterus, fallopian tubes, or ovaries and lead to long-term consequences ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240197.pdf

January 16th, 2025 Roche Molecular Systems, Inc. Deborah ... The cobas® liat. CT/NG/MG nucleic acid test is an automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time.