Recruiting PHASE4 Syphilis Infection

Tests treatment safety and results for Syphilis Infection

Official title The Efficacy of Doxycycline Post Exposure Prophylaxis for Preventing STIs Among MSM in Bangkok, Thailand.

ClinicalTrials.gov ID: NCT07397403

What this study is testing

What is Doxycycline (200mg/day)?

Doxycycline (200mg/day) is an investigational medicine, being studied as a potential treatment for syphilis infection.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The objective of this research is to evaluate the efficacy and safety of doxycycline in MSM for preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) in Thailand Participation in this study will last approximately 12 weeks and will include 2-3 clinic visits, along with 10-11 follow-up phone contacts over a period of 11 weeks.
  • Phase 4: studies an already-approved treatment
  • Time commitment: about 11 weeks

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 60, men only. Healthy volunteers may be eligible.

You may be able to join if

  • Biological male, aged not over 60 years
  • Thai nationality
  • Able to read, communicate, and understand the Thai language
  • Men who have sex with men (MSM), aged 18 years or older and not over 60 years
  • Having at least one of the following risk factors:

You likely can't join if

  • History of allergy to tetracycline-class antibiotics
  • Diagnosed with syphilis and not yet treated, or currently receiving treatment with benzathine penicillin G or doxycycline
  • Receipt of benzathine penicillin G within the past 12 weeks
  • Prior receipt of a gonorrhea vaccine
  • Current use of medications or products that may interact with doxycycline, including:
  • Vitamin A derivatives (e.g., isotretinoin, acitretin)
See the full eligibility criteria
Who can join
  • Biological male, aged not over 60 years
  • Thai nationality
  • Able to read, communicate, and understand the Thai language
  • Men who have sex with men (MSM), aged 18 years or older and not over 60 years
  • Having at least one of the following risk factors:
  • A history of condomless sex, or condom failure (breakage, leakage, or slippage), via any sexual route with at least two sexual partners within the past 3 months
  • A diagnosis of gonorrhea, chlamydia, or syphilis within the past 6 months
  • Current use of HIV pre-exposure prophylaxis (PrEP)
  • Willing and able to participate in study procedures (e.g., able to return to the clinic for scheduled testing for gonorrhea, chlamydia, and syphilis; able to complete doxycycline use records; and able to receive...
  • Willing and able to provide written informed consent to participate in the study
What rules you out
  • History of allergy to tetracycline-class antibiotics
  • Diagnosed with syphilis and not yet treated, or currently receiving treatment with benzathine penicillin G or doxycycline
  • Receipt of benzathine penicillin G within the past 12 weeks
  • Prior receipt of a gonorrhea vaccine
  • Current use of medications or products that may interact with doxycycline, including:
  • Vitamin A derivatives (e.g., isotretinoin, acitretin)
  • Antiepileptic drugs (e.g., phenytoin, carbamazepine, phenobarbital)
  • Immunosuppressive agents (e.g., methotrexate)
  • Medications for heart failure or cardiac arrhythmias (e.g., digoxin)
  • Anticoagulants (e.g., warfarin)
  • Use of oral or injectable medications that affect blood cells, such as anticancer drugs, chemotherapy, systemic corticosteroids, or targeted therapies
  • History of renal impairment (eGFR \ 3 times the upper limit of normal)
  • Uncontrolled or unstable underlying diseases, such as hematologic disorders, cancer, autoimmune diseases, or neurological disorders
  • Severe medical or psychiatric conditions that, in the investigator's judgment, may increase study-related risk or impair the participant's ability to provide informed consent
  • Alcohol dependence (inability to control alcohol consumption, withdrawal symptoms upon reduction or cessation, or continued use despite harm) or illicit drug dependence (regular, uncontrolled use) within the past 12...
  • Previous participation in this study with prior randomization

The study team makes the final eligibility decision.

Where it's taking place

  • Sathorn, Bangkok, Thailand

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 study runs about 11 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling male, 18 days to 60 days. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Sathorn, Bangkok, Thailand. 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.