Status:
RECRUITING
Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Post-exposure Prophylaxis
Sexually Transmitted Diseases
Eligibility:
MALE
18-100 years
Phase:
NA
Brief Summary
Post-exposure prophylaxis (PEP) using doxycycline 200 mg within 24 hours of unprotected sexual intercourse to prevent sexually transmitted infections has demonstrated a reduction in the incidence of c...
Eligibility Criteria
Inclusion
- Adult male patient
- Men who have Sex with Men (MSM) on PrEP or HIV-infected patients
- Patients who have not taken doxycycline for at least 3 months
- No symptoms of bacterial STI infection (chlamydia, gonorrhea, Mycoplasma genitalium or syphilis).
- Documented history of bacterial STI infection within the past 12 months
- Having had a risky intercourse within 24 hours and at the latest within 72 hours and for which a prescription of doxycycline in a single dose of 200 mg has been made within the framework of his usual follow-up.
- Free, informed, written consent, signed by the person and the investigator at the latest on the day of inclusion and before any examination carried out within the framework of the study (article L1122-1-1 of the Public Health Code).
- Person affiliated or benefiting from a social security system (article L1121-11 of the Public Health Code)
Exclusion
- Systemic treatment with retinoids (Acnetrait®, Procuta®, Curacné®, Contracné®, ....).
- Treatment with enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoin, etc.).
- Known allergy to antibiotics of the tetracycline family.
- Known allergy to one of the components of doxycycline tablets.
- Documented esophageal injury
- Ongoing treatment with doxycycline at the time of inclusion.
- Person participating in another research study with an exclusion period still in progress at inclusion.
- Persons under guardianship, conservatorship, or deprived of liberty by judicial or administrative decision.
- Patients on State Medical Aid
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 25 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06007534
Start Date
October 25 2023
End Date
April 25 2025
Last Update
September 19 2024
Active Locations (2)
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1
Hôpital Lariboisière AP-HP
Paris, France
2
Hôpital Saint Louis AP-HP
Paris, France