500-mg Versus 1000-mg Ceftriaxone for Uncomplicated Gonorrhea Infection
Recruiting now · Phase 3
Conditions studied: Gonorrhea Infection
In brief
This is a study to compare the treatment effect of different doses of ceftriaxone for gonorrhea.
Key facts
- Study ID
- NCT07710118
- Run by
- National Taiwan University Hospital
- People needed
- 400
- Starts
- 2026-07-01
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 18 years or older man, and
- having oropharyngeal, anorectal or urogenital N. gonorrhoeae infection confirmed by culture or a positive NAAT
You may not qualify if…
- 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.
- 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.
- A NAAT test positive for C. trachomatis or M. genitalium at the screening visit.
- 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.
Where it is running
- National Taiwan University Hospital — Taipei, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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