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Recruiting NCT07397403

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

Phase IV Interventional Syphilis Infection Gonorrhea Chlamydia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Doxycycline (200mg/day).
Who it may be relevant to
Registry conditions: Syphilis Infection, Gonorrhea, Chlamydia. Basic parameters: 18 Days — 60 Days · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Efficacy of Doxycycline Post Exposure Prophylaxis for Preventing Sexually Transmitted Diseases (Gonorrhea, Chlamydia, Syphilis) Among Men Who Have Sex With Men in Bangkok, Thailand.

Overview

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.

Interventions

  • Drug Doxycycline (200mg/day)
    Doxycycline 200 mg single dose after unprotected sex within 24-72 hours

Primary outcome measures

  • To evaluate the efficacy of doxycycline in preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) among men who have sex with men in Thailand. [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

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 follow-up phone calls from the research team)

Willing and able to provide written informed consent to participate in the study

\-

Exclusion criteria

  • 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 < 60 mL/min/1.73 m²) or hepatic impairment (AST or ALT > 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 months prior to enrollment, which may affect doxycycline use for STI prevention

Previous participation in this study with prior randomization

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Thailand · 1 center
  • Bangrak STIs Center — Sathorn

Publications

  • Frederiks WM, Kummerlin IP, Bosch KS, Vreeling-Sindelarova H, Jonker A, Van Noorden CJ. NADPH production by the pentose phosphate pathway in the zona fasciculata of rat adrenal gland. J Histochem Cytochem. 2007 Sep;55(9):975-80. doi: 10.1369/jhc.7A7222.2007. Epub 2007 May 28. PMID 17533217
  • Ren Z, Zhang P, Wang H, Wang H. Qualitative research investigating the mental health care service gap in Chinese burn injury patients. BMC Health Serv Res. 2018 Nov 28;18(1):902. doi: 10.1186/s12913-018-3724-3. PMID 30486854
  • Liu Q, Tong D, Yuan W, Liu G, Yuan G, Lan W, Zhang D, Zhang J, Huang Z, Zhang Y, Jiang J. Different RET gene mutation-induced multiple endocrine neoplasia type 2A in 3 Chinese families. Medicine (Baltimore). 2017 Jan;96(3):e5967. doi: 10.1097/MD.0000000000005967. PMID 28099363
  • Peyriere H, Makinson A, Marchandin H, Reynes J. Doxycycline in the management of sexually transmitted infections. J Antimicrob Chemother. 2018 Mar 1;73(3):553-563. doi: 10.1093/jac/dkx420. PMID 29182717
  • Stewart J, Oware K, Donnell D, Violette LR, Odoyo J, Soge OO, Scoville CW, Omollo V, Mogaka FO, Sesay FA, McClelland RS, Spinelli M, Gandhi M, Bukusi EA, Baeten JM; dPEP Kenya Study Team. Doxycycline Prophylaxis to Prevent Sexually Transmitted Infections in Women. N Engl J Med. 2023 Dec 21;389(25):2331-2340. doi: 10.1056/NEJMoa2304007. PMID 38118022
  • Molina JM, Bercot B, Assoumou L, Rubenstein E, Algarte-Genin M, Pialoux G, Katlama C, Surgers L, Bebear C, Dupin N, Ouattara M, Slama L, Pavie J, Duvivier C, Loze B, Goldwirt L, Gibowski S, Ollivier M, Ghosn J, Costagliola D; ANRS 174 DOXYVAC Study Group. Doxycycline prophylaxis and meningococcal group B vaccine to prevent bacterial sexually transmitted infections in France (ANRS 174 DOXYVAC): a m PMID 38797183
  • Luetkemeyer AF, Donnell D, Dombrowski JC, Cohen S, Grabow C, Brown CE, Malinski C, Perkins R, Nasser M, Lopez C, Vittinghoff E, Buchbinder SP, Scott H, Charlebois ED, Havlir DV, Soge OO, Celum C; DoxyPEP Study Team. Postexposure Doxycycline to Prevent Bacterial Sexually Transmitted Infections. N Engl J Med. 2023 Apr 6;388(14):1296-1306. doi: 10.1056/NEJMoa2211934. PMID 37018493
  • Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bebear C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Dore V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex PMID 29229440

Identifiers

NCT: NCT07397403 · 1/2568

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗