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NCT Number: NCT06007534

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Lariboisière AP-HP, Paris, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samples

Other

Blood samples, urine samples and oropharyngeal swabs before taking 200mg of doxycycline and then 2h, 24h, 48h, 7 days, 14 days, 60 days and 90 days after the single dose of doxycycline Hair samples: at the time of doxycycline administration, 1 month and 3 months after the single dose of doxycycline

Primary outcomes

  1. Concentration of doxycycline in urine

    Time frame: At Day 90

Secondary outcomes

  1. Concentration of doxycycline in plasma

    Time frame: Before the single intake of doxycycline

  2. Concentration of doxycycline in plasma

    Time frame: 2 hours after doxycycline intake

  3. Concentration of doxycycline in plasma

    Time frame: 24 hours after doxycycline intake

  4. Concentration of doxycycline in plasma

    Time frame: 48 hours after doxycycline intake

  5. Concentration of doxycycline in plasma

    Time frame: 7 days after doxycycline intake

  6. Concentration of doxycycline in plasma

    Time frame: 14 days after doxycycline intake

  7. Concentration of doxycycline in plasma

    Time frame: 30 days after doxycycline intake

  8. Concentration of doxycycline in plasma

    Time frame: 60 days after doxycycline intake

  9. Concentration of doxycycline in plasma

    Time frame: 90 days after doxycycline intake

  10. Concentration of doxycycline in whole blood

    Time frame: Before the single intake of doxycycline

  11. Concentration of doxycycline in whole blood

    Time frame: 2 hours after doxycycline intake

  12. Concentration of doxycycline in whole blood

    Time frame: 24 hours after doxycycline intake

  13. Concentration of doxycycline in whole blood

    Time frame: 48 hours after doxycycline intake

  14. Concentration of doxycycline in whole blood

    Time frame: 7 days after doxycycline intake

  15. Concentration of doxycycline in whole blood

    Time frame: 14 days after doxycycline intake

  16. Concentration of doxycycline in whole blood

    Time frame: 30 days after doxycycline intake

  17. Concentration of doxycycline in whole blood

    Time frame: 60 days after doxycycline intake

  18. Concentration of doxycycline in whole blood

    Time frame: 90 days after doxycycline intake

  19. Concentration of doxycycline in Dried Blood Spot (DBS)

    Time frame: Before the single intake of doxycycline

  20. Concentration of doxycycline in Dried Blood Spot (DBS)

    Time frame: 2 hours after doxycycline intake

  21. Concentration of doxycycline in Dried Blood Spot (DBS)

    Time frame: 24 hours after doxycycline intake

  22. Concentration of doxycycline in Dried Blood Spot (DBS)

    Time frame: 48 hours after doxycycline intake

  23. Concentration of doxycycline in Dried Blood Spot (DBS)

    Time frame: 7 days after doxycycline intake

  24. Concentration of doxycycline in Dried Blood Spot (DBS)

    Time frame: 14 days after doxycycline intake

  25. Concentration of doxycycline in Dried Blood Spot (DBS)

    Time frame: 30 days after doxycycline intake

  26. Concentration of doxycycline in Dried Blood Spot (DBS)

    Time frame: 60 days after doxycycline intake

  27. Concentration of doxycycline in Dried Blood Spot (DBS)

    Time frame: 90 days after doxycycline intake

  28. Concentration of doxycycline in urine

    Time frame: Before the single intake of doxycycline

  29. Concentration of doxycycline in urine

    Time frame: 2 hours after doxycycline intake

  30. Concentration of doxycycline in urine

    Time frame: 24 hours after doxycycline intake

  31. Concentration of doxycycline in urine

    Time frame: 48 hours after doxycycline intake

  32. Concentration of doxycycline in urine

    Time frame: 7 days after doxycycline intake

  33. Concentration of doxycycline in urine

    Time frame: 14 days after doxycycline intake

  34. Concentration of doxycycline in urine

    Time frame: 30 days after doxycycline intake

  35. Concentration of doxycycline in urine

    Time frame: 60 days after doxycycline intake

  36. Concentration of doxycycline in urine

    Time frame: 90 days after doxycycline intake

  37. Concentration of doxycycline in oropharyngeal secretions

    Time frame: Before the single intake of doxycycline

  38. Concentration of doxycycline in oropharyngeal secretions

    Time frame: 2 hours after doxycycline intake

  39. Concentration of doxycycline in oropharyngeal secretions

    Time frame: 24 hours after doxycycline intake

  40. Concentration of doxycycline in oropharyngeal secretions

    Time frame: 48 hours after doxycycline intake

  41. Concentration of doxycycline in oropharyngeal secretions

    Time frame: 7 days after doxycycline intake

  42. Concentration of doxycycline in oropharyngeal secretions

    Time frame: 14 days after doxycycline intake

  43. Concentration of doxycycline in oropharyngeal secretions

    Time frame: 30 days after doxycycline intake

  44. Concentration of doxycycline in oropharyngeal secretions

    Time frame: 60 days after doxycycline intake

  45. Concentration of doxycycline in oropharyngeal secretions

    Time frame: 90 days after doxycycline intake

  46. Concentration of doxycycline in rectal secretions

    Time frame: Before the single intake of doxycycline

  47. Concentration of doxycycline in rectal secretions

    Time frame: 2 hours after doxycycline intake

  48. Concentration of doxycycline in rectal secretions

    Time frame: 24 hours after doxycycline intake

  49. Concentration of doxycycline in rectal secretions

    Time frame: 48 hours after doxycycline intake

  50. Concentration of doxycycline in rectal secretions

    Time frame: 7 days after doxycycline intake

  51. Concentration of doxycycline in rectal secretions

    Time frame: 14 days after doxycycline intake

  52. Concentration of doxycycline in rectal secretions

    Time frame: 30 days after doxycycline intake

  53. Concentration of doxycycline in rectal secretions

    Time frame: 60 days after doxycycline intake

  54. Concentration of doxycycline in rectal secretions

    Time frame: 90 days after doxycycline intake

  55. Doxycycline concentration in hair

    Time frame: Before the single intake of doxycycline

  56. Doxycycline concentration in hair

    Time frame: 1 month after doxycycline intake

  57. Doxycycline concentration in hair

    Time frame: 3 months after doxycycline intake

  58. Number of biological matrix(es) associated with a quantifiable doxycycline dosage

    Time frame: Up to 15 days

    Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.

  59. Number of biological matrix(es) associated with a quantifiable doxycycline dosage

    Time frame: Up to 30 days

    Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.

  60. Number of biological matrix(es) associated with a quantifiable doxycycline dosage

    Time frame: Up to 60 days

    Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.

  61. Number of biological matrix(es) associated with a quantifiable doxycycline dosage

    Time frame: Up to 90 days

    Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.

  62. Cmax (maximum concentration) in plasma

    Time frame: Until day 90

  63. Cmax (maximum concentration) in whole blood

    Time frame: Until day 90

  64. Cmax (maximum concentration) in Dried Blood Spot (DBS)

    Time frame: Until day 90

  65. Cmax (maximum concentration) in urine

    Time frame: Until day 90

  66. Cmax (maximum concentration) in hair

    Time frame: Until day 90

  67. Cmax (maximum concentration) in rectal secretions

    Time frame: Until day 90

  68. AUC (area under the curve) in plasma

    Time frame: Until day 90

  69. AUC (area under the curve) in whole blood

    Time frame: Until day 90

  70. AUC (area under the curve) in Dried Blood Spot (DBS)

    Time frame: Until day 90

  71. AUC (area under the curve) in urine

    Time frame: Until day 90

  72. AUC (area under the curve) in hair

    Time frame: Until day 90

  73. AUC (area under the curve) in rectal secretions

    Time frame: Until day 90

  74. Elimination clearance in plasma

    Time frame: Until day 90

  75. Elimination clearance in whole blood

    Time frame: Until day 90

  76. Elimination clearance in Dried Blood Spot (DBS)

    Time frame: Until day 90

  77. Elimination clearance in urine

    Time frame: Until day 90

  78. Elimination clearance in hair

    Time frame: Until day 90

  79. Elimination clearance in rectal secretions

    Time frame: Until day 90

  80. Half-life in plasma

    Time frame: Until day 90

  81. Half-life in whole blood

    Time frame: Until day 90

  82. Half-life in Dried Blood Spot (DBS)

    Time frame: Until day 90

  83. Half-life in urine

    Time frame: Until day 90

  84. Half-life in hair

    Time frame: Until day 90

  85. Half-life in rectal secretions

    Time frame: Until day 90

  86. Mean residence time in plasma

    Time frame: Until day 90

  87. Mean residence time in whole blood

    Time frame: Until day 90

  88. Mean residence time in Dried Blood Spot (DBS)

    Time frame: Until day 90

  89. Mean residence time in urine

    Time frame: Until day 90

  90. Mean residence time in hair

    Time frame: Until day 90

  91. Mean residence time in rectal secretions

    Time frame: Until day 90

  92. Volume of distribution in plasma

    Time frame: Until day 90

  93. Volume of distribution in whole blood

    Time frame: Until day 90

  94. Volume of distribution in Dried Blood Spot (DBS)

    Time frame: Until day 90

  95. Volume of distribution in urine

    Time frame: Until day 90

  96. Volume of distribution in hair

    Time frame: Until day 90

  97. Volume of distribution in rectal secretions

    Time frame: Until day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Lambert, Dr

CONTACT

[email protected]

+33142499742

Lauriane GOLDWIRT, Dr

CONTACT

[email protected]

+33142494325

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: DOXY-PK

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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