Chlamydia Trachomatis InfectionNCT06369220
A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
A study testing cobas® liat CT/NG/MG nucleic acid test in people with Chlamydia Trachomatis Infection and Neisseria Gonorrhoeae Infection, run by Hoffmann-La Roche at 4 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Mycoplasma Genitalium Infection
- What is being tested?
- cobas® liat CT/NG/MG nucleic acid test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jul 2024to 28 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sexually active people
- People seeking medical services for symptoms consistent with a sexually transmitted infection (STI) and/or known exposure to an STI
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Planned Parenthood of Northern, Central, and Southern New Jersey, Inc.
Hamilton Square, New Jersey, 08690
Baylor Scott & White Health - Kileen
Killeen, Texas, 76543
Planned Parenthood of Northern, Central and Southern New Jersey
Perth Amboy, New Jersey, 08861
San Francisco City Clinic
San Francisco, California, 94103
About this study
Official title: A Study of the Clinical Utility of Point of Care Cobas® Liat CT/NG/MG Nucleic Acid Test Versus Current Standard Practice
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).
Read the detailed description
The study is designed as a block randomized, controlled 2-arm prospective study. The study targets to enroll approximatively 348 participants at increased risk of sexually transmitted infections (STIs)-participants who have known contact with CT/NG/MG (including participants who report knowledge or suspicion of STI exposure, despite the uncertainty of the specific STI pathogen or contact testing results), or participants with symptoms suggestive of STI-to participate in this study. Participants who give consent will provide demographic information and urogenital specimen(s) for CT/NG/MG testing on the cobas® liat system and for external laboratory-polymerase chain reaction (EL-PCR) testing. Participants will be randomized in a 1:1 ratio in blocks (of multiples of 2) stratified by the site to either of the following arms:
- Standard of Care (SOC)
- Point of Care (POC)
In both arms, the clinician will see and evaluate the participant and will complete a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter. The critical difference between the arms is that the clinician in the POC arm will be provided POC test results upon which they may choose to base their clinical decisions, whereas the SOC arm will not receive POC test results.
- Conditions
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Mycoplasma Genitalium Infection
- Being tested
- cobas® liat CT/NG/MG nucleic acid test, Standard of Care (SOC): Clinician's Standard Practice
- Keywords
- Sexually transmitted infections, Urogenital infections, Point of care testing
- Medical subject headings
- Gonorrhea, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cobas® liat CT/NG/MG nucleic acid testDiagnostic test
The cobas® CT/NG/MG nucleic acid test for use on the cobas® Liat® System is an investigational, automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) nucleic acid in male/female urine and vaginal swabs (clinician-collected and self-collected) in cobas® PCR Media.
Standard of Care (SOC): Clinician's Standard PracticeOther
Standard of care (SOC) is defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) Arm: Standard Practice | Other | In the SOC arm, the clinician will evaluate the participant based on standard practice. Receives: Other: Standard of Care (SOC): Clinician's Standard Practice |
| Point of Care (POC) Arm: cobas® liat CT/NG/MG | Experimental | 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. Receives: Diagnostic Test: cobas® liat CT/NG/MG nucleic acid test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG)
An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on the CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.
Measured: On the day of the medical encounter (Day 1)
Secondary outcomes (7)
Percentage of Participants Given Inappropriate Treatment for CT Infection
An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.
Measured: On the day of the medical encounter (Day 1)
Percentage of Participants Given Inappropriate Treatment for NG Infection
An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.
Measured: On the day of the medical encounter (Day 1)
Percentage of Participants Given Inappropriate Treatment for MG Infection
An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.
Measured: On the day of the medical encounter (Day 1)
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
The CSDT- Questionnaire assessed satisfaction with the test and SOC based on responses to the following: ease of use, time taken to perform, speed of results, ease of result interpretation, impact on the care plan, impact on consultations, impact on workload/workflow, and guidance and training, using a 5-point scale ranging from very satisfied to very dissatisfied. Only response categories with non-zero values are reported. Percentages have been rounded off.
Measured: Baseline until end of study (approximately 9.9 months)
Percentage of Clinicians With Confidence Scores for SOC and POC According to the CSDT-Q
The CSDT- Questionnaire assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off.
Measured: Baseline until end of study (approximately 9.9 months)
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
The PSDT- Questionnaire assessed satisfaction with the diagnostic test process based on responses to the following: overall visit satisfaction, information provision, ease of completion, time taken to perform, speed of results, method of results delivery, ease of understanding, accuracy, impact on clinical pathway, overall satisfaction, and satisfaction with sample or measurement collection bases on as: comfort, convenience, type of sample or measurement, person collecting sample or measurement, hygiene using a 5-point scale ranging from very satisfied to very dissatisfied. Percentages have been rounded off.
Measured: On the day of the medical encounter (Day 1)
Percentage of Participants With Confidence Scores for SOC and POC According to the PSDT-Q
The PSDT-Q assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off.
Measured: Baseline until end of study (approximately 9.9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start29 Jul 2024
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chlamydia Trachomatis InfectionStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Molecular Systems, Inc
- Responsible party
- Sponsor
- Investigators
- Zune Huynh, MD, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369220
- Sponsor's protocol ID
- LIA-STI-542
- Other IDs
- RD006616
- Status last verified
- Jun 2026
- First submitted
- 12 Apr 2024
- Last updated
- 13 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Clinical Utility of Point of Care Cobas® Liat CT/NG/MG Nucleic Acid Test Versus Current Standard Practice
- ClinicalTrials.gov ID
- NCT06369220
- Acronym / sponsor ID
- LIA-STI-542
- Conditions
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Mycoplasma Genitalium Infection
- Keywords
- Sexually transmitted infections, Urogenital infections, Point of care testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Roche Molecular Systems, Inc
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Posted 23 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study is designed as a block randomized, controlled 2-arm prospective study. The study targets to enroll approximatively 348 participants at increased risk of sexually transmitted infections (STIs)-participants who have known contact with CT/NG/MG (including participants who report knowledge or suspicion of STI exposure, despite the uncertainty of the specific STI pathogen or contact testing results), or participants with symptoms suggestive of STI-to participate in this study. Participants who give consent will provide demographic information and urogenital specimen(s) for CT/NG/MG testing on the cobas® liat system and for external laboratory-polymerase chain reaction (EL-PCR) testing. Participants will be randomized in a 1:1 ratio in blocks (of multiples of 2) stratified by the site to either of the following arms:
- Standard of Care (SOC)
- Point of Care (POC)
In both arms, the clinician will see and evaluate the participant and will complete a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter. The critical difference between the arms is that the clinician in the POC arm will be provided POC test results upon which they may choose to base their clinical decisions, whereas the SOC arm will not receive POC test results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) Arm: Standard Practice | Other | Other: Standard of Care (SOC): Clinician's Standard PracticeIn the SOC arm, the clinician will evaluate the participant based on standard practice. |
| Point of Care (POC) Arm: cobas® liat CT/NG/MG | Experimental | Diagnostic Test: cobas® liat CT/NG/MG nucleic acid testIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sexually active people
- People seeking medical services for symptoms consistent with a sexually transmitted infection (STI) and/or known exposure to an STI
Key exclusion criteria (10 listed)
- Previously enrolled in the study
- Unable to provide informed consent
- Currently pregnant
- Declines POC testing
- Presents for routine STI screening (asymptomatic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cobas® liat CT/NG/MG nucleic acid testThe cobas® CT/NG/MG nucleic acid test for use on the cobas® Liat® System is an investigational, automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) nucleic acid in male/female urine and vaginal swabs (clinician-collected and self-collected) in cobas® PCR Media. | Diagnostic test | Point of Care (POC) Arm: cobas® liat CT/NG/MG |
| Standard of Care (SOC): Clinician's Standard PracticeStandard of care (SOC) is defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. | Other | Standard of Care (SOC) Arm: Standard Practice |
Primary outcome
Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG)
Time frame: On the day of the medical encounter (Day 1)
An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on the CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.
7 secondary outcomes
Percentage of Participants Given Inappropriate Treatment for CT Infection
Time frame: On the day of the medical encounter (Day 1)
Percentage of Participants Given Inappropriate Treatment for NG Infection
Time frame: On the day of the medical encounter (Day 1)
Percentage of Participants Given Inappropriate Treatment for MG Infection
Time frame: On the day of the medical encounter (Day 1)
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Time frame: Baseline until end of study (approximately 9.9 months)
Percentage of Clinicians With Confidence Scores for SOC and POC According to the CSDT-Q
Time frame: Baseline until end of study (approximately 9.9 months)
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Time frame: On the day of the medical encounter (Day 1)
Percentage of Participants With Confidence Scores for SOC and POC According to the PSDT-Q
Time frame: Baseline until end of study (approximately 9.9 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chlamydia Trachomatis Infection
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Not yet recruiting
Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Recruiting
Improving Maternal and Child Health Through Point-of-care STI Testing
Treponema Pallidum Infection, Chlamydia Trachomatis Infection
Recruiting
Healthy Expectancy Through Routine Antenatal STI Screening
Antenatal Health, Antenatal Care
RecruitingObservational study
Using Urine to Study Antibodies & Functional Cell-Mediated Immunity in the Context of Chlamydia Trachomatis
Chlamydia Trachomatis Genital Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zune Huynh, MD study director
Hoffmann-La Roche
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cobas® liat CT/NG/MG nucleic acid test in people with Chlamydia Trachomatis Infection and Neisseria Gonorrhoeae Infection, run by Hoffmann-La Roche at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG) (time frame: On the day of the medical encounter (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.