Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well a single dose of doxycycline, an antibiotic, works as a way to prevent sexually transmitted infections (STIs) after unprotected sex. Specifically, it looks at how doxycycline is absorbed in different parts of the body, such as blood and urine, in men who have sex with men and are at risk for infections like chlamydia or syphilis. Previous research has shown that taking doxycycline within 24 hours after risky intercourse can significantly lower the chances of getting these infections.

To be eligible for this trial, participants must be adult men who have had unprotected sex within the last 72 hours and who are either on HIV prevention medication (PrEP) or currently HIV-positive. They should not have taken doxycycline in the past three months and must not show any signs of an STI at the time of enrollment. Participants will provide samples like blood and urine to help researchers understand how well the medication is working in their bodies. It's important to note that this trial is currently recruiting participants, and those interested should be aware of the specific inclusion criteria and potential exclusions before signing up.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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