[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"doxycycline\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:doxycycline":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100575884","sti-prophylaxis-and-emergence-of-antimicrobial-resistance-100575884",false,"NCT06778083","STI Prophylaxis and Emergence of Antimicrobial Resistance","SPEAR","Inclusion Criteria:\n\n* Aged ≥ 18 years.\n* Identifies as a man (cis or trans).\n* Has sex with men.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Use of an antibiotic other than doxycycline in the 3 months prior to enrolment\n* Currently being treated for an STI with doxycycline\n* Use of doxycycline within the prior 3 months for an indication other than STI treatment or STI prevention.",true,"MALE","18 Years",{"count":20,"type":21},108,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to understand the risk of antibiotic resistance and changes in the human microbiome (bacteria that live inside and on us), if people use antibiotics to prevent sexually transmitted infections (STI prophylaxis, doxycycline post-exposure prophylaxis, or 'doxyPEP'). The study will assess how easy and acceptable it is to find antibiotic resistance and microbiome changes in the throats and guts of men-who-have-sex-with-men (MSM) who use STI prophylaxis.\n\nThe study will recruit 108 MSM who are using and not using STI prophylaxis. Participants will visit the clinic every 6 months. At each visit, they will provide a throat swab and stool sample, and complete a questionnaire. DNA of the bacteria from the samples will be analysed to identify the bacteria and look for antibiotic resistance.",[25,26,27,28,29],"Sexually Transmitted Infection (STI) Prevention","Antibiotic Prophylaxis","Antibiotic Resistance, Bacterial","Microbiome","Doxycycline",[31,32,29,33,34,35,28,36],"DoxyPEP","STI Prophylaxis","STI Prevention","Antimicrobial Resistance","Antibiotic Resistance","Men-who-have-sex-with-men","RECRUITING","2025-03-26",{"date":40,"type":41},"2025-03-27","ACTUAL",{"date":43,"type":41},"2025-02-10",{"date":45,"type":21},"2027-04-30",{"name":47,"class":48},"University College, London","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":5},"100516669","pharmacokinetic-characterization-of-a-single-200-mg-dose-of-doxycycline-in-post-exposure-prophylaxis-pep-of-sexually-transmitted-infections-in-different-biological-compartments-100516669","NCT06007534","Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments","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","DOXY-PK","Inclusion Criteria:\n\n* Adult male patient\n* Men who have Sex with Men (MSM) on PrEP or HIV-infected patients\n* Patients who have not taken doxycycline for at least 3 months\n* No symptoms of bacterial STI infection (chlamydia, gonorrhea, Mycoplasma genitalium or syphilis).\n* Documented history of bacterial STI infection within the past 12 months\n* 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.\n* 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).\n* Person affiliated or benefiting from a social security system (article L1121-11 of the Public Health Code)\n\nExclusion Criteria:\n\n* Systemic treatment with retinoids (Acnetrait®, Procuta®, Curacné®, Contracné®, ....).\n* Treatment with enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoin, etc.).\n* Known allergy to antibiotics of the tetracycline family.\n* Known allergy to one of the components of doxycycline tablets.\n* Documented esophageal injury\n* Ongoing treatment with doxycycline at the time of inclusion.\n* Person participating in another research study with an exclusion period still in progress at inclusion.\n* Persons under guardianship, conservatorship, or deprived of liberty by judicial or administrative decision.\n* Patients on State Medical Aid","100 Years",{"count":60,"type":21},25,"INTERVENTIONAL",[63],"NA","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.\n\nThe 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.\n\nThe 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.",[66,67,29],"Post-exposure Prophylaxis","Sexually Transmitted Diseases","2024-09-13",{"date":70,"type":41},"2024-09-19",{"date":72,"type":41},"2023-10-25",{"date":74,"type":21},"2025-04-25",{"name":76,"class":48},"Assistance Publique - Hôpitaux de Paris"]