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New treatment option for Post-exposure Prophylaxis
Official title Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments
ClinicalTrials.gov ID: NCT06007534
What this study is testing
- What it's testing
- 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 chlamydial and syphilis infections and syphilis infection by 70% and 73% in men who have sex with men (MSM) undergoing pre-exposure prophylaxis prophylaxis (PrEP) for HIV. Other studies are underway or in development on doxycycline prophylaxis for bacterial STIs, which are particularly common in this population.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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...
- Person affiliated or benefiting from a social security system (article L1121-11 of the Public Health Code)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.