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

NCT05581160 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2024-10-08

No results posted yet for this study

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.

Conditions

  • Sexually Transmitted Infections (Not HIV or Hepatitis)
  • Chlamydia Trachomatis Infection
  • Neisseria Gonorrhoeae Infection
  • Mycoplasma 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.

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    collaborator OTHER_GOV

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

    lead OTHER

Principal Investigators

  • Karine Lacombe, Pr, PhD · IPLESP INSERM UMR-S1136

  • Laure Surgers, MD · Service des Maladies Infectieuses et Tropicales Hôpital Saint-Antoine

  • Martin Siguier, MD · Service des Maladies Infectieuses et Tropicales et Tenon Hôpital

  • Christophe Rodriguez, MD · INSERM U955 Eq18 CHU Henri Mondor

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2024-09-27
Completion
2024-09-27

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05581160 on ClinicalTrials.gov