Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Proportion of antibiotic prescriptions avoided using POCT cobas® Liat® CT/NG — 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.

Trial sites (2)

More Hospices Civils de Lyon trials in France