New Test for Sexually Transmitted Infections

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

348 Participants Needed

Trial Summary

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 data supports the effectiveness of the cobas® liat CT/NG/MG Test for detecting sexually transmitted infections?

The cobas® CT/NG test, used on the Cobas® 6800/8800 Systems, has shown high accuracy in detecting Chlamydia trachomatis and Neisseria gonorrhoeae, with over 98.5% agreement with another established test. This suggests it is a reliable tool for screening sexually transmitted infections. ^{1 2 3 4 5}

Is the cobas® CT/NG/MG Test safe for humans?

The cobas® CT/NG/MG Test is primarily used for detecting sexually transmitted infections and has been shown to be highly accurate in identifying infections like Chlamydia and Gonorrhea. There is no specific safety data mentioned, but the test is widely used in clinical settings, suggesting it is generally considered safe for human use. ^{1 2 3 4 5}

How is the cobas® liat CT/NG/MG Test different from other treatments for sexually transmitted infections?

The cobas® liat CT/NG/MG Test is unique because it offers a high-throughput, automated solution for screening sexually transmitted infections, providing rapid and accurate detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium from various specimen types, which is crucial for effective STI control. ^{1 2 3 4 6}

What is the purpose of this trial?

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 treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG).

Research Team

Zune Huynh, MD

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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 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]

References

1. Hungary 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. [2020]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Roche cobas® CT/NG test for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in male urine. [2019]

4. United States 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. [2021]

5. England 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. [2021]

6. England 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. [2020]