This is a study to compare the treatment effect of different doses of ceftriaxone for gonorrhea.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
single-dose ceftriaxone 500-mg intramuscular injection, dissolved in 2 mL of 1% lidocaine hydrochloride solution
single-dose ceftriaxone 1000-mg intramuscular injection, dissolved in 3.5 mL of 1% lidocaine hydrochloride solution
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGTreatment 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.
Time frame: From enrollment to 14 days after treatment
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.
Time frame: From enrollment to 14 days after treatment
Treatment-related adverse events
Treatment-related adverse events until 14 days after treatment.
Time frame: 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.
Time frame: From enrollment to 14 days after treatment
NG-MAST
NG-MAST at screening and TOC visits.
Time frame: 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.
Time frame: From enrollment to 14 days after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.