- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06216964
Time to Clearance of Chlamydia Trachomatis and Neisseria Gonorrhoeae RNA After Treatment: a Prospective Cohort Study (DECHLAGO)
January 11, 2024 updated by: University Hospital, Strasbourg, France
The aim of this study is to evaluate the negativation time of chlamydial and gonococcal PCRs after treatment for urogenital, oropharyngeal and anal infections.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Axel Ursenbach, MD
- Phone Number: 0033.88.15.13.52
- Email: axel.ursenbach@chru-strasbourg.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Estimate the rate of negativation of NAATs performed at the various sites of CT infection
Time Frame: 4 weeks after initiation of treatment
|
4 weeks after initiation of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
January 11, 2024
First Submitted That Met QC Criteria
January 11, 2024
First Posted (Actual)
January 22, 2024
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 11, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Neisseriaceae Infections
- Chlamydiaceae Infections
- Sexually Transmitted Diseases, Bacterial
- Urogenital Diseases
- Genital Diseases
- Chlamydia Infections
- Gonorrhea
Other Study ID Numbers
- 9188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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