At a glance
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Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST)
In Brief
A clinical study evaluating Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST) for Sexually Transmitted Infections (Not HIV or Hepatitis) and 3 related conditions. Completed, enrolled 332 participants across 2 sites.
Detailed Summary
The main objective of the study will be to assess the performance of the Next-Generation-Sequencing (NGS) diagnostics of Chlamydia trachomatis and Neisseria gonorrhoeae compared to reference techniques.
Study Details
Timeline
Interventions
Proposal of the study to all eligible adult patients coming for pre-exposure prophylaxis (PrEP) consultations from the Infectious Diseases Department of Saint-Antoine and Tenon Hospitals (with delivery of a patient's information and signing an informed consent form). During each visit (D0, M3, M6, M9, M12 and intermediate visits), patients will be asked to: * Respond to a questionnaire on their history of taking antibiotics, STIs, their foreign travels, their consumption of tobacco, drugs, alcohol and their sexual practices. * Perform the following additional samples at each visit, including the intermediate: rectal and throat swabs, urine sample and swab from the lesions in the case of ulceration presence due to STIs. The diagnosis of STIs (NG and MG) will be carried out using 2 techniques: the reference technique and the Next-Generation-Sequencing (NGS) technique. A serum sample will be collected during routine care. All samples will be stored after the analysis under -80° C.