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

Chlamydia Trachomatis Clinical Trial

— DECHLAGO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06216964
• Other study ID #: 9188
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Strasbourg, France
• Contact: Axel Ursenbach, MD
• Phone: 0033.88.15.13.52
• Email: axel.ursenbach[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis
• Gonorrhea
• Neisseria Gonorrhoeae

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the rate of negativation of NAATs performed at the various sites of CT infection		4 weeks after initiation of treatment