Recruiting NCT07710118
500-mg Versus 1000-mg Ceftriaxone for Uncomplicated Gonorrhea Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ceftriaxone 500-mg, ceftriaxone 1000-mg.
- Who it may be relevant to
- Registry conditions: Gonorrhea Infection. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
500-mg Versus 1000-mg Ceftriaxone for Uncomplicated Gonorrhea Infection: A Noninferiority Randomized Controlled Trial
Overview
This is a study to compare the treatment effect of different doses of ceftriaxone for gonorrhea.
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.
Interventions
- Drug ceftriaxone 500-mg
single-dose ceftriaxone 500-mg intramuscular injection, dissolved in 2 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
Primary outcome measures
- Treatment response of UGI [Time frame: From enrollment to 14 days after treatment]
Secondary outcome measures (5)
- Symptom duration [Time frame: From enrollment to 14 days after treatment]
- Treatment-related adverse events [Time frame: From enrollment to 14 days after treatment]
- MIC of ceftriaxone of isolates [Time frame: From enrollment to 14 days after treatment]
- NG-MAST [Time frame: From enrollment to 14 days after treatment]
- Gene mutations associated with drug resistance for extended-spectrum cephalosporins [Time frame: From enrollment to 14 days after treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT07710118 · 202504117MINB