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Post-exposure ProphylaxisDOXY-PKNCT06007534

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

A study testing Samples in people with Post-exposure Prophylaxis and Sexually Transmitted Diseases, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years, men onlyHealthy volunteers can take part
What is being tested?
Samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesFrance
Study dates
25 Oct 2023to 25 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Lauriane GOLDWIRT, Dr contact

+33142494325

lauriane.goldwirt@aphp.fr

Jérôme Lambert, Dr contact

+33142499742

jerome.lambert@u-paris.fr

France2 sites, 2 recruiting

  • Hôpital Lariboisière AP-HP

    Paris

    Agathe Rami, Dr, agathe.rami@aphp.fr

    Recruiting

  • Hôpital Saint Louis AP-HP

    Paris

    Jean-Michel Molina, Pr, jean-michel.molina@aphp.fr

    Recruiting

Other trials in France

About this study

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

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.

Being tested
Samples
Medical subject headings
Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SamplesOther

    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

Study groups in NCT06007534
Study groupRoleWhat they receive
Adult male patientOtherMen having Sex with Men on PrEP (pre-Exposition Prophylaxy) regularly taking doxycycline for Sexually Transmitted Infection (STI) prevention or HIV-infected
Receives: Other: Samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration of doxycycline in urine

    Measured: At Day 90

Secondary outcomes (97)

  1. Concentration of doxycycline in plasma

    Measured: Before the single intake of doxycycline

  2. Concentration of doxycycline in plasma

    Measured: 2 hours after doxycycline intake

  3. Concentration of doxycycline in plasma

    Measured: 24 hours after doxycycline intake

  4. Concentration of doxycycline in plasma

    Measured: 48 hours after doxycycline intake

  5. Concentration of doxycycline in plasma

    Measured: 7 days after doxycycline intake

  6. Concentration of doxycycline in plasma

    Measured: 14 days after doxycycline intake

  7. Concentration of doxycycline in plasma

    Measured: 30 days after doxycycline intake

  8. Concentration of doxycycline in plasma

    Measured: 60 days after doxycycline intake

  9. Concentration of doxycycline in plasma

    Measured: 90 days after doxycycline intake

  10. Concentration of doxycycline in whole blood

    Measured: Before the single intake of doxycycline

  11. Concentration of doxycycline in whole blood

    Measured: 2 hours after doxycycline intake

  12. Concentration of doxycycline in whole blood

    Measured: 24 hours after doxycycline intake

  13. Concentration of doxycycline in whole blood

    Measured: 48 hours after doxycycline intake

  14. Concentration of doxycycline in whole blood

    Measured: 7 days after doxycycline intake

  15. Concentration of doxycycline in whole blood

    Measured: 14 days after doxycycline intake

  16. Concentration of doxycycline in whole blood

    Measured: 30 days after doxycycline intake

  17. Concentration of doxycycline in whole blood

    Measured: 60 days after doxycycline intake

  18. Concentration of doxycycline in whole blood

    Measured: 90 days after doxycycline intake

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

    Measured: Before the single intake of doxycycline

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

    Measured: 2 hours after doxycycline intake

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

    Measured: 24 hours after doxycycline intake

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

    Measured: 48 hours after doxycycline intake

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

    Measured: 7 days after doxycycline intake

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

    Measured: 14 days after doxycycline intake

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

    Measured: 30 days after doxycycline intake

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

    Measured: 60 days after doxycycline intake

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

    Measured: 90 days after doxycycline intake

  28. Concentration of doxycycline in urine

    Measured: Before the single intake of doxycycline

  29. Concentration of doxycycline in urine

    Measured: 2 hours after doxycycline intake

  30. Concentration of doxycycline in urine

    Measured: 24 hours after doxycycline intake

  31. Concentration of doxycycline in urine

    Measured: 48 hours after doxycycline intake

  32. Concentration of doxycycline in urine

    Measured: 7 days after doxycycline intake

  33. Concentration of doxycycline in urine

    Measured: 14 days after doxycycline intake

  34. Concentration of doxycycline in urine

    Measured: 30 days after doxycycline intake

  35. Concentration of doxycycline in urine

    Measured: 60 days after doxycycline intake

  36. Concentration of doxycycline in urine

    Measured: 90 days after doxycycline intake

  37. Concentration of doxycycline in oropharyngeal secretions

    Measured: Before the single intake of doxycycline

  38. Concentration of doxycycline in oropharyngeal secretions

    Measured: 2 hours after doxycycline intake

  39. Concentration of doxycycline in oropharyngeal secretions

    Measured: 24 hours after doxycycline intake

  40. Concentration of doxycycline in oropharyngeal secretions

    Measured: 48 hours after doxycycline intake

  41. Concentration of doxycycline in oropharyngeal secretions

    Measured: 7 days after doxycycline intake

  42. Concentration of doxycycline in oropharyngeal secretions

    Measured: 14 days after doxycycline intake

  43. Concentration of doxycycline in oropharyngeal secretions

    Measured: 30 days after doxycycline intake

  44. Concentration of doxycycline in oropharyngeal secretions

    Measured: 60 days after doxycycline intake

  45. Concentration of doxycycline in oropharyngeal secretions

    Measured: 90 days after doxycycline intake

  46. Concentration of doxycycline in rectal secretions

    Measured: Before the single intake of doxycycline

  47. Concentration of doxycycline in rectal secretions

    Measured: 2 hours after doxycycline intake

  48. Concentration of doxycycline in rectal secretions

    Measured: 24 hours after doxycycline intake

  49. Concentration of doxycycline in rectal secretions

    Measured: 48 hours after doxycycline intake

  50. Concentration of doxycycline in rectal secretions

    Measured: 7 days after doxycycline intake

  51. Concentration of doxycycline in rectal secretions

    Measured: 14 days after doxycycline intake

  52. Concentration of doxycycline in rectal secretions

    Measured: 30 days after doxycycline intake

  53. Concentration of doxycycline in rectal secretions

    Measured: 60 days after doxycycline intake

  54. Concentration of doxycycline in rectal secretions

    Measured: 90 days after doxycycline intake

  55. Doxycycline concentration in hair

    Measured: Before the single intake of doxycycline

  56. Doxycycline concentration in hair

    Measured: 1 month after doxycycline intake

  57. Doxycycline concentration in hair

    Measured: 3 months after doxycycline intake

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

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

    Measured: Up to 15 days

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

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

    Measured: Up to 30 days

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

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

    Measured: Up to 60 days

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

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

    Measured: Up to 90 days

  62. Cmax (maximum concentration) in plasma

    Measured: Until day 90

  63. Cmax (maximum concentration) in whole blood

    Measured: Until day 90

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

    Measured: Until day 90

  65. Cmax (maximum concentration) in urine

    Measured: Until day 90

  66. Cmax (maximum concentration) in hair

    Measured: Until day 90

  67. Cmax (maximum concentration) in rectal secretions

    Measured: Until day 90

  68. AUC (area under the curve) in plasma

    Measured: Until day 90

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

    Measured: Until day 90

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

    Measured: Until day 90

  71. AUC (area under the curve) in urine

    Measured: Until day 90

  72. AUC (area under the curve) in hair

    Measured: Until day 90

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

    Measured: Until day 90

  74. Elimination clearance in plasma

    Measured: Until day 90

  75. Elimination clearance in whole blood

    Measured: Until day 90

  76. Elimination clearance in Dried Blood Spot (DBS)

    Measured: Until day 90

  77. Elimination clearance in urine

    Measured: Until day 90

  78. Elimination clearance in hair

    Measured: Until day 90

  79. Elimination clearance in rectal secretions

    Measured: Until day 90

  80. Half-life in plasma

    Measured: Until day 90

  81. Half-life in whole blood

    Measured: Until day 90

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

    Measured: Until day 90

  83. Half-life in urine

    Measured: Until day 90

  84. Half-life in hair

    Measured: Until day 90

  85. Half-life in rectal secretions

    Measured: Until day 90

  86. Mean residence time in plasma

    Measured: Until day 90

  87. Mean residence time in whole blood

    Measured: Until day 90

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

    Measured: Until day 90

  89. Mean residence time in urine

    Measured: Until day 90

  90. Mean residence time in hair

    Measured: Until day 90

  91. Mean residence time in rectal secretions

    Measured: Until day 90

  92. Volume of distribution in plasma

    Measured: Until day 90

  93. Volume of distribution in whole blood

    Measured: Until day 90

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

    Measured: Until day 90

  95. Volume of distribution in urine

    Measured: Until day 90

  96. Volume of distribution in hair

    Measured: Until day 90

  97. Volume of distribution in rectal secretions

    Measured: Until day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start25 Oct 2023
  3. Primary completion25 Apr 2025 (estimated)
  4. Study completion25 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06007534
Sponsor's protocol ID
APHP221156
Acronym
DOXY-PK
Status last verified
Aug 2024
First submitted
30 Jun 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Samples in people with Post-exposure Prophylaxis and Sexually Transmitted Diseases, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lauriane GOLDWIRT, Dr (+33142494325, lauriane.goldwirt@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of doxycycline in urine (time frame: At Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06007534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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