[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gonorrhea-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gonorrhea-infection":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100647601","phase-3-500-mg-versus-1000-mg-ceftriaxone-for-uncomplicated-gonorrhea-infection-100647601",false,"NCT07710118","500-mg Versus 1000-mg Ceftriaxone for Uncomplicated Gonorrhea Infection","500-mg Versus 1000-mg Ceftriaxone for Uncomplicated Gonorrhea Infection: A Noninferiority Randomized Controlled Trial","Inclusion Criteria:\n\n* 18 years or older man, and\n* having oropharyngeal, anorectal or urogenital N. gonorrhoeae infection confirmed by culture or a positive NAAT\n\nExclusion Criteria:\n\n* Suspicion of a complicated N. gonorrhoeae infection. Complicated N. gonorrhoeae infection is defined as the presence of epididymitis, arthritis, bacteremia, conjunctivitis, or disseminated gonococcal infection.\n* Use of systemic cephalosporins, doxycycline, or azithromycin at the screening visit or within 30 days prior to the enrollment visit is prohibited. Participants who require immediate antibiotic treatment at the screening visit, based on clinician judgment or shared decision-making with the participant, without awaiting PCR or culture confirmation, will be excluded from the study. Use of doxycycline for post-exposure prophylaxis (Doxy-PEP) is permitted.\n* A NAAT test positive for C. trachomatis or M. genitalium at the screening visit.\n* A history of allergy or intolerance to ceftriaxone, penicillins, or lidocaine, in alignment with the contraindications listed in the Sintrix (ceftriaxone) injection package insert. Allergy or intolerance is defined as the occurrence of adverse symptoms following antibiotic administration, including but not limited to skin rash, pruritus, dyspnea, angioedema, anaphylaxis, dizziness, nausea, vomiting, headache, or diarrhea. Laboratory abnormalities include cytopenias, eosinophilia, and elevated levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, or creatinine. Penicillins include natural penicillins (e.g., penicillin G), aminopenicillins (e.g., amoxicillin, ampicillin), penicillinase-resistant penicillins (e.g., oxacillin, dicloxacillin), extended-spectrum penicillins (e.g., piperacillin), and other agents classified within the penicillin class.","MALE","18 Years",{"count":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a study to compare the treatment effect of different doses of ceftriaxone for gonorrhea.",[26],"Gonorrhea Infection",[28,29,30,31],"gonorrhea","sexually transmitted infection","PCR","ceftriaxone","RECRUITING","2026-07-12",{"date":35,"type":36},"2026-07-17","ACTUAL",{"date":38,"type":20},"2026-07",{"date":40,"type":20},"2029-06",{"name":42,"class":43},"National Taiwan University Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100636762","a-study-to-evaluate-the-performance-usability-and-contrived-result-interpretation-of-istatis-gonorrhea-antigen-test-100636762","NCT07569900","A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test","A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test by Trained Personnel at Near-Patient or Point-of-Care Settings","Inclusion Criteria\n\n* Age \\> 16 years\n* Subject (or legally authorized representative) is willing to provide written informed consent before any study procedures\n* Female gender\n* Subject is able and willing to provide vaginal swab specimen for study procedures (3-4 swabs)\n* Subject can complete the required testing on the allocated testing day\n* Subject can speak, read, and write English\n* Subject's demographic information, risk factors, and symptoms are available and can be recorded on case report forms\n* Subject agrees to comply with study procedures and sample collection for both the investigational device and the reference method\n* Subject is willing to participate in the study site's standard-of-care Gonorrhea counselling and testing program and receive standard-of-care test results, as required and applicable\n* Subject is indicated for sexually transmitted infection testing for one or more of the following reasons:\n\n  * At risk of Gonorrhea, such as recent unprotected intercourse, multiple or new partners within \\\u003C 60 days, known exposure to an infected partner, or prior STI history\n  * Having signs and\u002For symptoms suggestive of Gonorrhea (e.g., urethral, vaginal, rectal, or pharyngeal discharge; dysuria; pelvic or lower-abdominal pain; sore throat; or rectal discomfort)\n  * Undergoing routine or opportunistic STI screening, including family-planning, antenatal, or sexual-health clinic visits\n  * Undergoing re-testing (test-of-cure) \\> 7 days after completion of Gonorrhea treatment and clinically stable\n  * Undergoing co-testing for other STIs where Gonorrhea testing is part of a broader diagnostic panel\n\nExclusion Criteria\n\n* Subject 15 years of age or younger\n* Male gender\n* Female currently menstruating\n* Subject is unable or unwilling to provide informed consent\n* Subject is medically unstable or has psychiatric condition(s) that pose a risk or prevent study compliance\n* Subject is unable to provide paired samples for reference testing\n* Subject requires urgent antimicrobial treatment before specimen collection\n* Subject received systemic or topical antibiotics active against Gonorrhea within the previous 7 days\n* Subject used topical intravaginal or rectal antiseptics within 48 hours prior to study sampling\n* Previously enrolled for the same infection episode\n* Anatomical or clinical contraindication to study sampling (e.g., severe cervical pathology)\n* Recent urogenital procedure (e.g., cystoscopy, lavage) \\\u003C 72 hours before study sampling\n* Subject belongs to a protected group excluded by local ethics (e.g., incarcerated persons), unless explicitly approved by the EC\u002FIRB\n* Any condition that, in the opinion of trained personnel or study staff, would make the participant unsuitable or unsafe for enrolment, interfere with completion of assessments, consent, or questionnaires, or bias study outcomes\n* Subject is participating in another interventional clinical study within 30 days that could interfere with study results",true,"FEMALE","16 Years",{"count":56,"type":20},650,[58],"NA","The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by trained personnel.",[26],[62,63,64],"Gonorrhea test","Point-of-care test","iStatis test","2026-06-30",{"date":67,"type":36},"2026-07-02",{"date":69,"type":36},"2025-11-26",{"date":71,"type":20},"2027-01-01",{"name":73,"class":74},"bioLytical Laboratories","INDUSTRY",3]