500-mg Versus 1000-mg Ceftriaxone for Uncomplicated Gonorrhea Infection

NCT07710118 | Recruiting Phase 3

• 1 other identifier: 202504117MINB
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to compare the treatment effect of different doses of ceftriaxone for gonorrhea.

Conditions

Gonorrhea Infection

Keywords

gonorrhea; sexually transmitted infection; PCR; ceftriaxone

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to 14 days after treatment

Secondary Outcomes (5)

• Symptom duration

  From enrollment to 14 days after treatment

• Treatment-related adverse events

  From enrollment to 14 days after treatment

• MIC of ceftriaxone of isolates

  From enrollment to 14 days after treatment

• NG-MAST

  From enrollment to 14 days after treatment

• Gene mutations associated with drug resistance for extended-spectrum cephalosporins

  From enrollment to 14 days after treatment

Study Arms (2)

500-mg ceftriaxone

EXPERIMENTAL

single-dose ceftriaxone 500-mg intramuscular injection, dissolved in 2 mL of 1% lidocaine hydrochloride solution

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

Drug: ceftriaxone 1000-mg

Interventions

ceftriaxone 500-mg DRUG

single-dose ceftriaxone 500-mg intramuscular injection, dissolved in 2 mL of 1% lidocaine hydrochloride solution

500-mg ceftriaxone

ceftriaxone 1000-mg DRUG

single-dose ceftriaxone 1000-mg intramuscular injection, dissolved in 3.5 mL of 1% lidocaine hydrochloride solution

1000-mg ceftriaxone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital Hsin-Chu Branch: collaborator
• Far Eastern Memorial Hospital: collaborator
• National Taiwan University Hospital, Yun-Lin Branch: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Gonorrhea; Sexually Transmitted Diseases

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Tzong-Yow Wu, M.D.

CONTACT

886+933594074; retep0102@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

TW (1)