Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST) (NGS-IST)
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- STATUS
- Recruiting
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- End date
- Feb 11, 2024
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- participants needed
- 207
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- sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
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.
Description
Sexually Transmitted Infections (STIs) have become a major global public health problem and are among the most common infections. The increase antibiotic resistance, particularly in Neisseria gonorrhoeae and Mycoplasma genitalium, is of concern. Currently, the diagnosis of STIs is based on specific tests by pathogen, mainly by standard culture allowing an antibiotic susceptibility testing, gene amplification tests possibly allowing the search for resistance genes and serologies.
Next-Generation-Sequencing (NGS) is based on the detection and analysis of any DNA and RNA present in the studied sample with a high degree of sensitivity, this method enables the precise identification of non-human sequences regardless its bacterial, viral or parasitologic origin, to detect resistance genes and to characterize the strains.
The investigators propose to assess the performance of NGS for the diagnosis of STIs. A cohort of 207 PrEP users from Saint-Antoine Hospital will be followed every 3 months for 1 year for this purpose.
The main objective of the study will be to assess the performance of the NGS diagnostics of Chlamydia trachomatis and Neisseria gonorrhoeae compared to reference techniques.
The secondary objectives will be (i) to evaluate the performance of the diagnosis by NGS of the other STIs compared to the reference techniques, (ii) to evaluate the interest and the sensitivity of a 3 sites pooled sample "urine, throat and rectum" for the diagnosis of STIs, (iii) to describe the natural history of colonization with Mycoplasma genitalium and the appearance of resistance or pressure of antibiotic selection and (iv) to evaluate the prevalence of agents not usually sought in screening for STI (HSV-1, HSV-2, Haemophilus ducreyi, Campylobacter sp, Shigella sp, Clostridioides difficile, Entamoeba histolytica).
Improved diagnosis of STIs and resistance will allow better patient management.
Details
| Condition | Sexually Transmitted Infections (Not HIV or Hepatitis), Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Mycoplasma Genitalium Infection |
|---|---|
| Treatment | Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST) |
| Clinical Study Identifier | NCT05581160 |
| Sponsor | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba |
| Last Modified on | 11 April 2023 |
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