New Test for Sexually Transmitted Infections

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Hoffmann-La Roche

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

Disqualifiers: Pregnancy, Routine screening, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

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).

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}

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.

Trial 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 (Virus Therapy)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Planned Parenthood of Northern, Central, and Southern New Jersey, Inc. Delran, NJ

San Francisco City Clinic San Francisco, CA

Baylor Scott & White Health - Kileen Killeen, TX

Planned Parenthood of Northern, Central and Southern New Jersey Perth Amboy, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2482

Patients Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Roche Molecular Systems, Inc

Industry Sponsor

Trials

5

Patients Recruited

9,600+

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]