Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST)

NACompletedINTERVENTIONAL
Enrollment

332

Participants

Timeline

Start Date

July 11, 2022

Primary Completion Date

September 27, 2024

Study Completion Date

September 27, 2024

Conditions
Sexually Transmitted Infections (Not HIV or Hepatitis)Chlamydia Trachomatis InfectionNeisseria Gonorrhoeae InfectionMycoplasma Genitalium Infection
Interventions
DIAGNOSTIC_TEST

Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST)

"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."

Trial Locations (2)

75012

Service des Maladies Infectieuses et Tropicales Hôpital Saint-Antoine, Paris

75020

Service des Maladies Infectieuses et Tropicales Hôpital Tenon, Paris

All Listed Sponsors
collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

lead

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

OTHER