Gonorrhea InfectionPhase 3NCT07710118
500-mg Versus 1000-mg Ceftriaxone for Uncomplicated Gonorrhea Infection
A Phase 3 study testing ceftriaxone 500-mg and ceftriaxone 1000-mg in people with Gonorrhea Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a study to compare the treatment effect of different doses of ceftriaxone for gonorrhea. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Gonorrhea Infection
- What is being tested?
- ceftriaxone 500-mg and ceftriaxone 1000-mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2026to Jun 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older man, and
- having oropharyngeal, anorectal or urogenital N. gonorrhoeae infection confirmed by culture or a positive NAAT
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Tzong-Yow Wu, M.D., 886+933594074, retep0102@gmail.com
About this study
Official title: 500-mg Versus 1000-mg Ceftriaxone for Uncomplicated Gonorrhea Infection: A Noninferiority Randomized Controlled Trial
This is a study to compare the treatment effect of different doses of ceftriaxone for gonorrhea.
Read the detailed description
This is a noninferiority randomized controlled trial to compare the treatment effect of 500-mg to 1000-mg of ceftriaxone for uncomplicated gonorrhea infection in men.
- Conditions
- Gonorrhea Infection
- Being tested
- ceftriaxone 500-mg, ceftriaxone 1000-mg
- Keywords
- gonorrhea, sexually transmitted infection, PCR, ceftriaxone
- Medical subject headings
- Gonorrhea, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftriaxone 500-mgDrug
single-dose ceftriaxone 500-mg intramuscular injection, dissolved in 2 mL of 1% lidocaine hydrochloride solution
ceftriaxone 1000-mgDrug
single-dose ceftriaxone 1000-mg intramuscular injection, dissolved in 3.5 mL of 1% lidocaine hydrochloride solution
| Study group | Role | What they receive |
|---|---|---|
| 500-mg ceftriaxone | Experimental | single-dose ceftriaxone 500-mg intramuscular injection, dissolved in 2 mL of 1% lidocaine hydrochloride solution Receives: Drug: ceftriaxone 500-mg |
| 1000-mg ceftriaxone | Active comparator | single-dose ceftriaxone 1000-mg intramuscular injection, dissolved in 3.5 mL of 1% lidocaine hydrochloride solution Receives: Drug: ceftriaxone 1000-mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response of UGI
The proportion of participants with successful treatment of UGI, defined as a NAAT-negative and, if applicable, a culture-negative result of the primary anatomic sites of infection 7-14 days after treatment; a culture-negative result is required only if N. gonorrhoeae culture was positive at the screening visit.
Measured: From enrollment to 14 days after treatment
Secondary outcomes (5)
Symptom duration
Symptom duration, including dysuria, genital discharge, sore throat, anorectal pain, rectal bleeding, and rectal discharge, in the subgroup of patients who have baseline symptoms attributable to UGIs.
Measured: From enrollment to 14 days after treatment
Treatment-related adverse events
Treatment-related adverse events until 14 days after treatment.
Measured: From enrollment to 14 days after treatment
MIC of ceftriaxone of isolates
MIC of ceftriaxone of isolates at screening and test-of-cure (TOC) visits.
Measured: From enrollment to 14 days after treatment
NG-MAST
NG-MAST at screening and TOC visits.
Measured: From enrollment to 14 days after treatment
Gene mutations associated with drug resistance for extended-spectrum cephalosporins
Gene mutations associated with drug resistance for extended-spectrum cephalosporins at screening and TOC visits.
Measured: From enrollment to 14 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gonorrhea InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch, Far Eastern Memorial Hospital, National Taiwan University Hospital, Yun-Lin Branch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710118
- Sponsor's protocol ID
- 202504117MINB
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided