An interventional study of cobas® Liat® CT/NG Point-of-Care Test in Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection and Sexually Transmitted Infections, sponsored by Hospices Civils de Lyon. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
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.
159 studies on the registry are indexed under Gonorrhea; 28 are open to participants now.
This study's planned enrollment of 404 is close to the median of 380 across 120 interventional studies indexed under Gonorrhea.
Browse Gonorrhea studies →Hospices Civils de Lyon is the lead sponsor of 1,854 studies on the registry; 441 are open to participants now.
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Exclusion Criteria:
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.
Diagnostic Test: cobas® Liat® CT/NG Point-of-Care 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.
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.
Time frame: Day 0 (data collected at the inclusion consultation for each participant)
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.
Time frame: 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
Time frame: 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.
Time frame: through study completion, an average of 1 year
Start is estimated for Dec 2026; primary completion for Dec 2026, 0 months later.
Of 36 non-industry interventional studies with no phase under Gonorrhea, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 0 months is below that.
Counting every sponsor, half of 39 studies reached it within 20 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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