500-mg vs 1000-mg Ceftriaxone for Uncomplicated Gonorrhea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 noninferiority randomized trial comparing two ceftriaxone doses for uncomplicated gonorrhea in men. Participants are adults with oropharyngeal, anal, or urogenital gonorrhea confirmed by culture or a positive NAAT. The study aims to determine if the lower dose achieves similar cure rates to the higher dose while avoiding unnecessary higher-dose exposure. Exclusions include complicated gonorrhea, recent systemic antibiotic use, and co-infection with certain pathogens or ceftriaxone allergy. The trial is conducted at multiple centers in Taiwan and is sponsored by National Taiwan University Hospital with several collaborating sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years or older man, and
* having oropharyngeal, anorectal or urogenital N. gonorrhoeae infection confirmed by culture or a positive NAAT

Exclusion Criteria:

* 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's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Tzong-Yow Wu, M.D.
• Email: retep0102@gmail.com
• Phone: 886+933594074

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.