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

NCT ID: NCT06216964

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-05
• Study Completion Date: 2027-11-01

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.

Conditions

Chlamydia Trachomatis; Neisseria Gonorrhoeae; Uncomplicated Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) NAAT(s)

Test every week after the start of treatment, until NAAT negativation and up to a maximum of 4 weeks

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service du Trait d'Union

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Axel Ursenbach, MD

Role: CONTACT

axel.ursenbach@chru-strasbourg.fr

0033.88.15.13.52

Facility Contacts

Axel URSENBACH, MD

Role: primary

Other Identifiers

9188

Identifier Type: -

Identifier Source: org_study_id