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NOT YET RECRUITING
NCT07884656
NA

Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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. 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.

Official title: Optimizing Prescription Through Targeted Immediate Management in Sexual Health Environments

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

404

Start Date

2026-12-01

Completion Date

2027-12-31

Last Updated

2026-10-20

Healthy Volunteers

Yes

Interventions

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.

Locations (2)

Centre gratuit d'information de dépistage et de diagnostic des infections (CeGIDD), Hopital Edouard Herriot Groupement Hospitalier Centre

Lyon, France

Centre gratuit d'information de dépistage et de diagnostic des infections (CeGIDD), Hopital de la Croix Rousse. Groupement Hospitalier Nord

Lyon, France