Clinical trial NCT06007534: Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments
Official title: Caractérisation de la pharmacocinétique d'Une Dose Unique de 200 mg de Doxycycline en Prophylaxie Post-exposition (PEP) Des Infections Sexuellement Transmissibles Dans différents Compartiments Biologiques
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-exposure Prophylaxis
Sexually Transmitted Diseases
Doxycycline
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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. Monitoring adherence to PEP is of great interest in guaranteeing the effectiveness of this strategy and to be able to assess the uptake of PEP among PrEP users. Among the many methods for assessing adherence, measuring drug concentrations is a more accurate measure of adherence than self-reporting.

The therapeutic monitoring of doxycycline and the assessment of adherence have been described using plasma and hair samples, allowing estimation of intake over the last 3-4 days and 4 months, respectively. Nevertheless, these biological matrices present several limitations for application in clinical practice: reflecting the duration of exposure should be more in line with the frequency of visits (2 months), and the collection of hair samples may be difficult due to refusal or short hair. On the other hand, interpretation of the hair assay is limited by the degradation of doxycycline in this matrix, which could lead to underestimation of drug intake. By Therefore, new biological matrices are needed for more accurate assessment of doxycycline adherence in post-exposure prevention monitoring.

The objective is to evaluate the pharmacokinetics of doxycycline in plasma, whole blood, dried blood spots (DBS), urine and hair after a single dose of doxycycline in men using oral doxycycline for post-exposure prophylaxis of sexually transmitted infections (syphilis or Chlamydia trachomatis) and having sex with men.


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

Primary outcomes:
measure: Concentration of doxycycline in urine
timeFrame: At Day 90
Secondary outcomes:
measure: Concentration of doxycycline in plasma
timeFrame: Before the single intake of doxycycline
measure: Concentration of doxycycline in plasma
timeFrame: 2 hours after doxycycline intake
measure: Concentration of doxycycline in plasma
timeFrame: 24 hours after doxycycline intake
measure: Concentration of doxycycline in plasma
timeFrame: 48 hours after doxycycline intake
measure: Concentration of doxycycline in plasma
timeFrame: 7 days after doxycycline intake
measure: Concentration of doxycycline in plasma
timeFrame: 14 days after doxycycline intake
measure: Concentration of doxycycline in plasma
timeFrame: 30 days after doxycycline intake
measure: Concentration of doxycycline in plasma
timeFrame: 60 days after doxycycline intake
measure: Concentration of doxycycline in plasma
timeFrame: 90 days after doxycycline intake
measure: Concentration of doxycycline in whole blood
timeFrame: Before the single intake of doxycycline
measure: Concentration of doxycycline in whole blood
timeFrame: 2 hours after doxycycline intake
measure: Concentration of doxycycline in whole blood
timeFrame: 24 hours after doxycycline intake
measure: Concentration of doxycycline in whole blood
timeFrame: 48 hours after doxycycline intake
measure: Concentration of doxycycline in whole blood
timeFrame: 7 days after doxycycline intake
measure: Concentration of doxycycline in whole blood
timeFrame: 14 days after doxycycline intake
measure: Concentration of doxycycline in whole blood
timeFrame: 30 days after doxycycline intake
measure: Concentration of doxycycline in whole blood
timeFrame: 60 days after doxycycline intake
measure: Concentration of doxycycline in whole blood
timeFrame: 90 days after doxycycline intake
measure: Concentration of doxycycline in Dried Blood Spot (DBS)
timeFrame: Before the single intake of doxycycline
measure: Concentration of doxycycline in Dried Blood Spot (DBS)
timeFrame: 2 hours after doxycycline intake
measure: Concentration of doxycycline in Dried Blood Spot (DBS)
timeFrame: 24 hours after doxycycline intake
measure: Concentration of doxycycline in Dried Blood Spot (DBS)
timeFrame: 48 hours after doxycycline intake
measure: Concentration of doxycycline in Dried Blood Spot (DBS)
timeFrame: 7 days after doxycycline intake
measure: Concentration of doxycycline in Dried Blood Spot (DBS)
timeFrame: 14 days after doxycycline intake
measure: Concentration of doxycycline in Dried Blood Spot (DBS)
timeFrame: 30 days after doxycycline intake
measure: Concentration of doxycycline in Dried Blood Spot (DBS)
timeFrame: 60 days after doxycycline intake
measure: Concentration of doxycycline in Dried Blood Spot (DBS)
timeFrame: 90 days after doxycycline intake
measure: Concentration of doxycycline in urine
timeFrame: Before the single intake of doxycycline
measure: Concentration of doxycycline in urine
timeFrame: 2 hours after doxycycline intake
measure: Concentration of doxycycline in urine
timeFrame: 24 hours after doxycycline intake
measure: Concentration of doxycycline in urine
timeFrame: 48 hours after doxycycline intake
measure: Concentration of doxycycline in urine
timeFrame: 7 days after doxycycline intake
measure: Concentration of doxycycline in urine
timeFrame: 14 days after doxycycline intake
measure: Concentration of doxycycline in urine
timeFrame: 30 days after doxycycline intake
measure: Concentration of doxycycline in urine
timeFrame: 60 days after doxycycline intake
measure: Concentration of doxycycline in urine
timeFrame: 90 days after doxycycline intake
measure: Concentration of doxycycline in oropharyngeal secretions
timeFrame: Before the single intake of doxycycline
measure: Concentration of doxycycline in oropharyngeal secretions
timeFrame: 2 hours after doxycycline intake
measure: Concentration of doxycycline in oropharyngeal secretions
timeFrame: 24 hours after doxycycline intake
measure: Concentration of doxycycline in oropharyngeal secretions
timeFrame: 48 hours after doxycycline intake
measure: Concentration of doxycycline in oropharyngeal secretions
timeFrame: 7 days after doxycycline intake
measure: Concentration of doxycycline in oropharyngeal secretions
timeFrame: 14 days after doxycycline intake
measure: Concentration of doxycycline in oropharyngeal secretions
timeFrame: 30 days after doxycycline intake
measure: Concentration of doxycycline in oropharyngeal secretions
timeFrame: 60 days after doxycycline intake
measure: Concentration of doxycycline in oropharyngeal secretions
timeFrame: 90 days after doxycycline intake
measure: Concentration of doxycycline in rectal secretions
timeFrame: Before the single intake of doxycycline
measure: Concentration of doxycycline in rectal secretions
timeFrame: 2 hours after doxycycline intake
measure: Concentration of doxycycline in rectal secretions
timeFrame: 24 hours after doxycycline intake
measure: Concentration of doxycycline in rectal secretions
timeFrame: 48 hours after doxycycline intake
measure: Concentration of doxycycline in rectal secretions
timeFrame: 7 days after doxycycline intake
measure: Concentration of doxycycline in rectal secretions
timeFrame: 14 days after doxycycline intake
measure: Concentration of doxycycline in rectal secretions
timeFrame: 30 days after doxycycline intake
measure: Concentration of doxycycline in rectal secretions
timeFrame: 60 days after doxycycline intake
measure: Concentration of doxycycline in rectal secretions
timeFrame: 90 days after doxycycline intake
measure: Doxycycline concentration in hair
timeFrame: Before the single intake of doxycycline
measure: Doxycycline concentration in hair
timeFrame: 1 month after doxycycline intake
measure: Doxycycline concentration in hair
timeFrame: 3 months after doxycycline intake
measure: Number of biological matrix(es) associated with a quantifiable doxycycline dosage
timeFrame: Up to 15 days
measure: Number of biological matrix(es) associated with a quantifiable doxycycline dosage
timeFrame: Up to 30 days
measure: Number of biological matrix(es) associated with a quantifiable doxycycline dosage
timeFrame: Up to 60 days
measure: Number of biological matrix(es) associated with a quantifiable doxycycline dosage
timeFrame: Up to 90 days
measure: Cmax (maximum concentration) in plasma
timeFrame: Until day 90
measure: Cmax (maximum concentration) in whole blood
timeFrame: Until day 90
measure: Cmax (maximum concentration) in Dried Blood Spot (DBS)
timeFrame: Until day 90
measure: Cmax (maximum concentration) in urine
timeFrame: Until day 90
measure: Cmax (maximum concentration) in hair
timeFrame: Until day 90
measure: Cmax (maximum concentration) in rectal secretions
timeFrame: Until day 90
measure: AUC (area under the curve) in plasma
timeFrame: Until day 90
measure: AUC (area under the curve) in whole blood
timeFrame: Until day 90
measure: AUC (area under the curve) in Dried Blood Spot (DBS)
timeFrame: Until day 90
measure: AUC (area under the curve) in urine
timeFrame: Until day 90
measure: AUC (area under the curve) in hair
timeFrame: Until day 90
measure: AUC (area under the curve) in rectal secretions
timeFrame: Until day 90
measure: Elimination clearance in plasma
timeFrame: Until day 90
measure: Elimination clearance in whole blood
timeFrame: Until day 90
measure: Elimination clearance in Dried Blood Spot (DBS)
timeFrame: Until day 90
measure: Elimination clearance in urine
timeFrame: Until day 90
measure: Elimination clearance in hair
timeFrame: Until day 90
measure: Elimination clearance in rectal secretions
timeFrame: Until day 90
measure: Half-life in plasma
timeFrame: Until day 90
measure: Half-life in whole blood
timeFrame: Until day 90
measure: Half-life in Dried Blood Spot (DBS)
timeFrame: Until day 90
measure: Half-life in urine
timeFrame: Until day 90
measure: Half-life in hair
timeFrame: Until day 90
measure: Half-life in rectal secretions
timeFrame: Until day 90
measure: Mean residence time in plasma
timeFrame: Until day 90
measure: Mean residence time in whole blood
timeFrame: Until day 90
measure: Mean residence time in Dried Blood Spot (DBS)
timeFrame: Until day 90
measure: Mean residence time in urine
timeFrame: Until day 90
measure: Mean residence time in hair
timeFrame: Until day 90
measure: Mean residence time in rectal secretions
timeFrame: Until day 90
measure: Volume of distribution in plasma
timeFrame: Until day 90
measure: Volume of distribution in whole blood
timeFrame: Until day 90
measure: Volume of distribution in Dried Blood Spot (DBS)
timeFrame: Until day 90
measure: Volume of distribution in urine
timeFrame: Until day 90
measure: Volume of distribution in hair
timeFrame: Until day 90
measure: Volume of distribution in rectal secretions
timeFrame: Until day 90
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière AP-HP
city: Paris
country: France
facility: Hôpital Saint Louis AP-HP
Study officials:
References: