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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06216964
Other study ID # 9188
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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