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

NCT06216964 | Recruiting

• 1 other identifier: 9188
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Estimate the rate of negativation of NAATs performed at the various sites of CT infection

  4 weeks after initiation of treatment

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service du Trait d'Union

Strasbourg, 67000, France

RECRUITING

Central Study Contacts

Axel Ursenbach, MD

CONTACT

0033.88.15.13.52; axel.ursenbach@chru-strasbourg.fr

Study Design

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

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: April 5, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)