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

NCT05581160 | Completed

• 1 other identifier: IMEA62
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Metagenomics Next-Generation-Sequencing (NGS); Sexually Transmitted Infections (STI); Pre-Exposure Prophylaxis (PrEP); Men who have Sex with Men (MSM)

Outcome Measures

Primary Outcomes (1)

• To evaluate the performance of NGS metagenomic diagnosis of Chlamydia trachomatis (Ct) and Neisseria gonorrhoeae (Ng) compared to reference techniques.

  Sensitivity, specificity, positive and negative predictive values of NGS compared to reference techniques for Ng and Ct.

  12 months

Secondary Outcomes (8)

• To evaluate the performance of the diagnosis by NGS of the other STIs compared to the reference techniques.

  12 months

• Describe the epidemiology of circulating strains by molecular typing.

  12 months

• Estimate the incidence and describe the natural history of colonization by Mycoplasma genitalium (Mg).

  12 months

• Estimate the incidence of the appearance of Mycoplasma genitalium resistance under antibiotic selection pressure.

  12 months

• Characterize circulating Neisseria gonorrhoeae (Ng) clones.

  12 months

Study Arms (1)

12-months prospective multicenter longitudinal cohort with the biological samples collection.

EXPERIMENTAL

This is a single-arm interventional study. After acceptance of the study (signature of the informed consent form), patients are included in the single-arm interventional study for a period of 12 months with follow-up visits every 3 months and intermediate visits in the case of the symptoms presence or sexual contacts with partners having STIs (corresponding to standard care for the PrEP users).

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

Interventions

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

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.

12-months prospective multicenter longitudinal cohort with the biological samples collection.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men who have sex with men (MSM).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• MSM
• PrEP users
• Acceptance of study constraints
• With or without Social Security scheme or State Medical Aid
• Signature of consent form to participate in the study

You may not qualify if:

• Language barrier making questioning impossible.

Sponsors & Collaborators

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: lead
• ANRS, Emerging Infectious Diseases: collaborator

Study Sites (2)

Service des Maladies Infectieuses et Tropicales Hôpital Saint-Antoine

Paris, 75012, France

Location

Service des Maladies Infectieuses et Tropicales Hôpital Tenon

Paris, 75020, France

Location

Related Publications (18)

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MeSH Terms

Conditions

Sexually Transmitted Diseases; Hepatitis; Gonorrhea; Homosexuality

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Sexuality; Sexual Behavior; Behavior

Study Officials

• Karine Lacombe, Pr, PhD

  IPLESP INSERM UMR-S1136

  STUDY CHAIR

• Laure Surgers, MD

  Service des Maladies Infectieuses et Tropicales Hôpital Saint-Antoine

  PRINCIPAL INVESTIGATOR

• Martin Siguier, MD

  Service des Maladies Infectieuses et Tropicales et Tenon Hôpital

  PRINCIPAL INVESTIGATOR

• Christophe Rodriguez, MD

  INSERM U955 Eq18 CHU Henri Mondor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 12-months prospective multicenter longitudinal cohort with the biological samples collection.

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: July 11, 2022
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: October 8, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)