Actively Recruiting
Pharmacokinetic Study of a Single 200 mg Dose of Doxycycline for Post-exposure Prophylaxis of Sexually Transmitted Infections in Men Who Have Sex with Men
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-09-19
25
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of doxycycline, taken as a single 200 mg dose, for post-exposure prophylaxis (PEP) to prevent sexually transmitted infections (STIs) such as syphilis and Chlamydia trachomatis, particularly in men who have sex with men (MSM) using pre-exposure prophylaxis (PrEP) for HIV or who are HIV-infected. The study aims to evaluate how doxycycline moves through different biological compartments, including plasma, whole blood, dried blood spots, urine, hair, and secretions, to better understand adherence to this preventative approach. This research addresses limitations in current methods of monitoring doxycycline intake, like plasma and hair sampling, by exploring new biological matrices for more accurate drug adherence assessment. Participants will receive a single 200 mg dose of doxycycline for PEP, and researchers will collect various biological samples including blood, urine, oropharyngeal and rectal swabs, and hair at multiple time points before and after administration. Sample collection times include before dosing, then at 2 hours, 24 hours, 48 hours, 7 days, 14 days, 30 days, 60 days, and 90 days after the dose, with hair samples taken at administration, 1 month, and 3 months later. This detailed sampling schedule aims to characterize the pharmacokinetics of doxycycline over time in different body compartments. During the study, participants will provide biological samples according to the schedule described. Researchers will measure doxycycline concentrations in these samples to assess drug levels and adherence. The main outcome is the concentration of doxycycline in urine at day 90, along with multiple secondary measures including concentrations in plasma, whole blood, dried blood spots, oropharyngeal and rectal secretions, and hair at various time points. The study will monitor drug parameters such as maximum concentration, area under the curve, elimination clearance, half-life, and volume of distribution up to day 90. Participation concludes after the final assessments at 90 days post-dose.
CONDITIONS
Brief Title
Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 prescribed a single 200 mg dose of doxycycline as part of usual follow-up
- Free, informed, written consent signed before any study procedure
- Person affiliated with or benefiting from a social security system
You will not qualify if you...
- Systemic treatment with retinoids (Acnetrait®, Procuta®, Curacné®, Contracné®, etc.)
- Treatment with enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoin, etc.)
- Known allergy to antibiotics of the tetracycline family
- Known allergy to any component of doxycycline tablets
- Documented esophageal injury
- Ongoing doxycycline treatment at inclusion
- Participation in another research study with an exclusion period still active
- Persons under guardianship, conservatorship, or deprived of liberty by judicial or administrative decision
- Patients on State Medical Aid
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 90 days
Participants provide blood, urine, oropharyngeal, rectal, and hair samples before and after taking a single 200 mg dose of doxycycline to measure drug concentrations in various biological compartments.
Visits at baseline and 2 hours, 24 hours, 48 hours, 7 days, 14 days, 30 days, 60 days, and 90 days after the dose
Trial Site Locations
Total: 2 locations
1
Hôpital Lariboisière AP-HP
Paris, France
Actively Recruiting
2
Hôpital Saint Louis AP-HP
Paris, France
Actively Recruiting
Research Team
L
Lauriane GOLDWIRT, Dr
J
Jérôme Lambert, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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