ceftriaxone 500-mg: single-dose ceftriaxone 500-mg intramuscular injection, dissolved in 2 mL of 1% lidocaine hydrochloride solution
ceftriaxone 1000-mg: single-dose ceftriaxone 1000-mg intramuscular injection, dissolved in 3.5 mL of 1% lidocaine hydrochloride solution
Study summary
This is a study to compare the treatment effect of different doses of ceftriaxone for gonorrhea.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Treatment response of UGI — From enrollment to 14 days after treatment 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.
Trial sites (1)
Facility
City
Region
Status
National Taiwan University Hospital
Taipei
Taiwan
Recruiting
More National Taiwan University Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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