Chlamydia Trachomatis InfectionOPTIMISENCT07884656
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
A study testing cobas® Liat® CT/NG Point-of-Care Test in people with Chlamydia Trachomatis Infection and Neisseria Gonorrhoeae Infection, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Sexually transmitted infections (STIs) caused by Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are increasing in France, with a significant proportion of asymptomatic infections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Sexually Transmitted Infections
- What is being tested?
- cobas® Liat® CT/NG Point-of-Care Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years old, sexually active, consulting in one of the participating CeGIDD clinics (Hospices Civils de Lyon)
- Presenting with either:
- Symptoms suggestive of Chlamydia trachomatis or Neisseria gonorrhoeae infection (e.g., urethral discharge, dysuria, rectal pain, abnormal vaginal discharge, odynophagia) OR
- Documented sexual exposure within the previous 14 days to a partner positive for CT and/or NG, without symptoms
- Able to understand the study information and provide written informed consent
Who cannot join
- Pregnancy or breastfeeding
- Refusal to undergo the POCT cobas® Liat® CT/NG test
- Asymptomatic patients presenting for routine screening only, without a documented exposure
- Recent antibiotic treatment active against CT, NG, or Mycoplasma genitalium within 21 days
- Technical or medical contraindication to sample collection (e.g., inability to perform urine or swab sampling)
- Persons under legal protection (guardianship, curatorship), minors, or individuals deprived of liberty
- Participation in another interventional study with an exclusion period overlapping the inclusion date
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Centre gratuit d'information de dépistage et de diagnostic des infections (CeGIDD), Hopital Edouard Herriot Groupement Hospitalier Centre
Lyon, 69003
Anne Sophie BATALLA-DELVINCOURT, MD, +33472116206, Anne-sophie.batalla-delvincourt@chu-lyon.fr
Centre gratuit d'information de dépistage et de diagnostic des infections (CeGIDD), Hopital de la Croix Rousse. Groupement Hospitalier Nord
Lyon, 69004
Maxime BONJOUR, Dr, +33426109473, maxime.bonjour@chu-lyon.fr
About this study
Official title: Optimizing Prescription Through Targeted Immediate Management in Sexual Health Environments
Sexually transmitted infections (STIs) caused by Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are increasing in France, with a significant proportion of asymptomatic infections. Standard management in sexual health clinics (called CeGIDD) relies on laboratory-based PCR tests with turnaround times of 24-72 hours, leading to frequent empirical antibiotic prescriptions, including broad-spectrum therapies. This practice contributes to antibiotic overuse and the emergence of antimicrobial resistance.
The OPTIMISE study evaluates the clinical impact of implementing the cobas® Liat® CT/NG point-of-care test (POCT) in CeGIDD settings. The hypothesis is that immediate, on-site molecular testing enables:
Read more
Significant reduction in unnecessary antibiotic prescriptions, particularly in asymptomatic exposed individuals, Targeted monotherapy in symptomatic patients, reducing broad-spectrum antibiotic exposure, Improved patient satisfaction and adherence through immediate diagnosis and treatment, Feasibility and acceptability of POCT integration in sexual health care pathways.
The study is a prospective, single-arm, bicentric interventional RIPH2 study including approximately 700 adults consulting in CeGIDD clinics of the Hospices Civils de Lyon, either for symptomatic STI suspicion or recent sexual exposure to CT/NG. Outcomes include the proportion of avoided antibiotic prescriptions, patient and provider satisfaction, and descriptive epidemiology of non-CT/NG pathogens.
- Conditions
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Sexually Transmitted Infections, Antimicrobial Resistance / Antibiotic Overuse
- Being tested
- cobas® Liat® CT/NG Point-of-Care Test
- Keywords
- Sexually transmitted infections, Point-of-care testing, Antibiotic stewardship, Neisseria gonorrhoeae, Chlamydia trachomatis
- 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 Point-of-Care TestDiagnostic test
Participants will undergo a point-of-care molecular test (cobas® Liat® CT/NG) performed on routine clinical samples (urine or vaginal swab). For extragenital samples (rectal or pharyngeal), the test will be used off-label, and the primary sample will also be sent for confirmatory PCR at the hospital laboratory. The POCT delivers results in approximately 20 minutes, enabling immediate clinical decision-making to reduce empirical antibiotic use. All participants will complete a short satisfaction questionnaire at the end of the consultation.
| Study group | Role | What they receive |
|---|---|---|
| POCT cobas® Liat® CT/NG - Single Arm | Experimental | Participants will undergo point-of-care testing (POCT) using the cobas® Liat® CT/NG assay on routine urogenital samples collected during their CeGIDD consultation. For extragenital samples (rectal or pharyngeal), the test will be performed off-label and results will be confirmed by standard laboratory PCR. The POCT provides results in approximately 20 minutes and allows immediate clinical decision-making, with the goal of reducing unnecessary empirical antibiotic prescriptions. Receives: Diagnostic Test: cobas® Liat® CT/NG Point-of-Care Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of antibiotic prescriptions avoided using POCT cobas® Liat® CT/NG
Percentage of participants for whom empirical or broad-spectrum antibiotic prescription was avoided due to immediate POCT results, compared with the theoretical standard-of-care prescribing strategy.
Measured: Day 0 (data collected at the inclusion consultation for each participant)
Secondary outcomes (3)
Patient satisfaction score regarding POCT-based care
Patient-reported satisfaction measured using a standardized self-administered questionnaire immediately after consultation, evaluating comfort, understanding, and perceived usefulness of rapid testing.
Measured: Day 0 (at the end of the consultation)
Healthcare Staff Satisfaction Index of integrating POCT into CeGIDD care pathways
staff satisfaction measured using a standardized self-administered French System Usability Scale (F-SUS) questionnaire
Measured: Throughout study duration (12-month inclusion period)
Prevalence of non-target urogenital pathogens detected by standard culture
Identification and proportion of other bacterial pathogens (e.g., Haemophilus spp.) isolated by routine culture in symptomatic participants, providing surveillance data complementary to POCT results.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion2 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chlamydia Trachomatis InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm, interventional RIPH2 study conducted in two CeGIDD clinics (Hospices Civils de Lyon) to assess the clinical impact of the cobas® Liat® CT/NG point-of-care test on antibiotic prescriptions and patient management.
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884656
- Sponsor's protocol ID
- 69HCL25_0785
- Other IDs
- 2026-A00458-43
- Acronym
- OPTIMISE
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Prescription Through Targeted Immediate Management in Sexual Health Environments
- ClinicalTrials.gov ID
- NCT07884656
- Acronym / sponsor ID
- OPTIMISE / 69HCL25_0785
- Conditions
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Sexually Transmitted Infections, Antimicrobial Resistance / Antibiotic Overuse
- Keywords
- Sexually transmitted infections, Point-of-care testing, Antibiotic stewardship, Neisseria gonorrhoeae, Chlamydia trachomatis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 2 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sexually transmitted infections (STIs) caused by Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are increasing in France, with a significant proportion of asymptomatic infections. Standard management in sexual health clinics (called CeGIDD) relies on laboratory-based PCR tests with turnaround times of 24-72 hours, leading to frequent empirical antibiotic prescriptions, including broad-spectrum therapies. This practice contributes to antibiotic overuse and the emergence of antimicrobial resistance.
The OPTIMISE study evaluates the clinical impact of implementing the cobas® Liat® CT/NG point-of-care test (POCT) in CeGIDD settings. The hypothesis is that immediate, on-site molecular testing enables:
Significant reduction in unnecessary antibiotic prescriptions, particularly in asymptomatic exposed individuals, Targeted monotherapy in symptomatic patients, reducing broad-spectrum antibiotic exposure, Improved patient satisfaction and adherence through immediate diagnosis and treatment, Feasibility and acceptability of POCT integration in sexual health care pathways.
The study is a prospective, single-arm, bicentric interventional RIPH2 study including approximately 700 adults consulting in CeGIDD clinics of the Hospices Civils de Lyon, either for symptomatic STI suspicion or recent sexual exposure to CT/NG. Outcomes include the proportion of avoided antibiotic prescriptions, patient and provider satisfaction, and descriptive epidemiology of non-CT/NG pathogens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, interventional RIPH2 study conducted in two CeGIDD clinics (Hospices Civils de Lyon) to assess the clinical impact of the cobas® Liat® CT/NG point-of-care test on antibiotic prescriptions and patient management.
| Arm | Type | Receives |
|---|---|---|
| POCT cobas® Liat® CT/NG - Single Arm | Experimental | Diagnostic Test: cobas® Liat® CT/NG Point-of-Care TestParticipants will undergo point-of-care testing (POCT) using the cobas® Liat® CT/NG assay on routine urogenital samples collected during their CeGIDD consultation. For extragenital samples (rectal or pharyngeal), the test will be performed off-label and results will be confirmed by standard laboratory PCR. The POCT provides results in approximately 20 minutes and allows immediate clinical decision-making, with the goal of reducing unnecessary empirical antibiotic prescriptions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥18 years old, sexually active, consulting in one of the participating CeGIDD clinics (Hospices Civils de Lyon)
- Presenting with either:
- Symptoms suggestive of Chlamydia trachomatis or Neisseria gonorrhoeae infection (e.g., urethral discharge, dysuria, rectal pain, abnormal vaginal discharge, odynophagia) OR
- Documented sexual exposure within the previous 14 days to a partner positive for CT and/or NG, without symptoms
- Able to understand the study information and provide written informed consent
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding
- Refusal to undergo the POCT cobas® Liat® CT/NG test
- Asymptomatic patients presenting for routine screening only, without a documented exposure
- Recent antibiotic treatment active against CT, NG, or Mycoplasma genitalium within 21 days
- Technical or medical contraindication to sample collection (e.g., inability to perform urine or swab sampling)
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 Point-of-Care TestParticipants will undergo a point-of-care molecular test (cobas® Liat® CT/NG) performed on routine clinical samples (urine or vaginal swab). For extragenital samples (rectal or pharyngeal), the test will be used off-label, and the primary sample will also be sent for confirmatory PCR at the hospital laboratory. The POCT delivers results in approximately 20 minutes, enabling immediate clinical decision-making to reduce empirical antibiotic use. All participants will complete a short satisfaction questionnaire at the end of the consultation. | Diagnostic test | POCT cobas® Liat® CT/NG - Single Arm |
Primary outcome
Proportion of antibiotic prescriptions avoided using POCT cobas® Liat® CT/NG
Time frame: Day 0 (data collected at the inclusion consultation for each participant)
Percentage of participants for whom empirical or broad-spectrum antibiotic prescription was avoided due to immediate POCT results, compared with the theoretical standard-of-care prescribing strategy.
3 secondary outcomes
Patient satisfaction score regarding POCT-based care
Time frame: Day 0 (at the end of the consultation)
Healthcare Staff Satisfaction Index of integrating POCT into CeGIDD care pathways
Time frame: Throughout study duration (12-month inclusion period)
Prevalence of non-target urogenital pathogens detected by standard culture
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
2 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 Point-of-Care Test in people with Chlamydia Trachomatis Infection and Neisseria Gonorrhoeae Infection, run by Hospices Civils de Lyon at 2 sites in France.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthieu GODINOT, Dr (+33472071107, matthieu.godinot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of antibiotic prescriptions avoided using POCT cobas® Liat® CT/NG (time frame: Day 0 (data collected at the inclusion consultation for each participant)). 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 20 Oct 2026.