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Rapid STI test aims to curb antibiotic misuse

NCT ID NCT06369220

Diagnosis Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study compares a new rapid point-of-care test for chlamydia, gonorrhea, and mycoplasma genitalium to standard lab testing. The goal is to see if the faster test helps doctors give the right antibiotics on the same day, reducing unnecessary or missed treatments. Participants are sexually active people with symptoms or known exposure to an STI.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cobas® liat CT/NG/MG nucleic acid test
What this could lead to
If successful, this rapid test could help doctors prescribe the right antibiotics on the spot, reducing over- and under-treatment for common sexually transmitted infections.
What could go wrong
The test may not be more accurate than current methods, and its impact on treatment decisions could be limited by practical factors like clinic workflow or cost.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

331 people

The number who actually took part.

Started

Jul 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Sexually active people * People seeking medical services for symptoms consistent with a sexually transmitted infection (STI) and/or known exposure to an STI Exclusion Criteria: * Previously enrolled in the study * Unable to provide informed consent * Currently pregnant * Declines POC testing * Presents for routine STI screening (asymptomatic) * Use of antimicrobial agents active against CT, NG, or MG during the 21 days before sample collection. Example of such antimicrobial agents include the following: Macrolides (e.g., azithromycin and erythromycin); Penicillins (e.g., amoxicillin); Tetracyclines (e.g., doxycycline); Fluoroquinolones (e.g., ciprofloxacin, ofloxacin, levofloxacin, and moxifloxacin); Cephalosporins (e.g., ceftriaxone and cefixime) * Use of phenazopyridine-containing urinary pain relief medicines (ie, Azo or Pyridium) within 2 days prior to sample collection * Use of any over-the-counter feminine hygiene products (internally or externally), such as vaginal moisturizers, lubricants (e.g., Replens, RepHresh, etc.), and feminine washes/vaginal douches, etc. within the 3 days prior to sample collection. The use of tampons or pads during menses is not an exclusionary criterion. * Contraindication to vaginal swab sampling where vaginal swab sampling is the only option available * Urination within 1 hour prior to sample collection (for subjects providing urine sample)

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Conditions

The condition(s) this trial relates to.

chlamydia trachomatis infectious disease gonorrhea Mycoplasmoides infection sexually transmitted disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chlamydia trachomatis infection Mycoplasma genitalium infection Neisseria gonorrhoeae infection

Contacts and locations

Locations

  • Baylor Scott & White Health - Kileen

    Killeen, Texas, 76543, United States

  • Planned Parenthood of Northern, Central and Southern New Jersey

    Perth Amboy, New Jersey, 08861, United States

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

    Hamilton Square, New Jersey, 08690, United States

  • San Francisco City Clinic

    San Francisco, California, 94103, United States

More trials for these conditions

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