Time to Clearance of Chlamydia Trachomatis and Neisseria Gonorrhoeae RNA After Treatment: a Prospective Cohort Study

Not Applicable

Recruiting

• Conditions: Neisseria Gonorrhoeae; Uncomplicated Infections; Chlamydia Trachomatis

• Registration Number: NCT06216964
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

The aim of this study is to evaluate the negativation time of chlamydial and gonococcal PCRs after treatment for urogenital, oropharyngeal and anal infections.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-22
• Study Start: 2024-04-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• • Patients attending the Trait d'Union department at the Nouvel Hôpital Civil for PrEP consultations, AES or HIV infection.
• Over 18 years of age
• Male or female
• Who have had an uncomplicated CT and/or NG infection treated with currently recommended therapies (Ceftriaxone 500mg DU for NG infections, Doxycycline 200mg per day for 1 week for rectal CT infections and Azithromycin 1g DU or Doxycycline 7 days for other CT infections).
• Subject affiliated to a social health insurance scheme
• Subject able to understand the aims and risks of the research and to give dated and signed informed consent

Exclusion Criteria

• • Complicated CT and/or NG infections: epididymitis, prostatitis, upper genital infection, extra-genital involvement (keratoconjunctivitis, arthritis, skin involvement, Fiessinger-Leroy-reiter syndrome, Fitz-Hugh-Curtis syndrome).
• Interfering treatments and associated diseases: Severe immunosuppression (HIV infection with CD4 less than 200/mm3, chemotherapy in the last 6 months, active haemopathy, congenital immune deficiency, immunosuppressive treatment including corticosteroid therapy for more than 4 weeks or organ transplant.
• Impossibility of giving the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.).
• Subject under court protection
• Subject under guardianship or curatorship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Estimate the rate of negativation of NAATs performed at the various sites of CT infection	4 weeks after initiation of treatment

Trial Locations

Locations (1)

Service du Trait d'Union; 🇫🇷 Strasbourg, France