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

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

Study Overview

• Status: Recruiting
• Conditions: Gonorrhea Infection
• Intervention / Treatment: Drug: ceftriaxone 500-mg; Drug: ceftriaxone 1000-mg

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

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

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Tzong-Yow Wu, M.D.; Phone Number: 886+933594074; Email: retep0102@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 500-mg ceftriaxone; single-dose ceftriaxone 500-mg intramuscular injection, dissolved in 2 mL of 1% lidocaine hydrochloride solution	Drug: ceftriaxone 500-mg; single-dose ceftriaxone 500-mg intramuscular injection, dissolved in 2 mL of 1% lidocaine hydrochloride solution
Active Comparator: 1000-mg ceftriaxone; single-dose ceftriaxone 1000-mg intramuscular injection, dissolved in 3.5 mL of 1% lidocaine hydrochloride solution	Drug: ceftriaxone 1000-mg; single-dose ceftriaxone 1000-mg intramuscular injection, dissolved in 3.5 mL of 1% lidocaine hydrochloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to 14 days after treatment
Treatment-related adverse events	Treatment-related adverse events until 14 days after treatment.	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.	From enrollment to 14 days after treatment
NG-MAST	NG-MAST at screening and TOC visits.	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.	From enrollment to 14 days after treatment

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Far Eastern Memorial Hospital; National Taiwan University Hospital Hsin-Chu Branch; National Taiwan University Hospital, Yun-Lin Branch

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: July 12, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: PCR; ceftriaxone; gonorrhea; sexually transmitted infection
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases; Gonorrhea; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; beta-Lactams; Lactams; Cephalosporins; Thiazines; Cefotaxime; Cephacetrile; Ceftriaxone
• Other Study ID Numbers: 202504117MINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No