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Efficacy and safety of ceftriaxone and spectinomycin in the treatment of uncomplicated genital gonorrhoeae infection: a multicenter randomized controlled study

Efficacy and safety of ceftriaxone and spectinomycin in the treatment of uncomplicated genital gonorrhoeae infection: a multicenter randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050261
Enrollment
Unknown
Registered
2021-08-24
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gonorrhoea

Interventions

control group:treated with ceftriaxone
treatment group:treated with spectinomycin

Sponsors

Dermatology Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 70 years, males or females; 2.Neisseria gonorrhoeae infection confirmed by culture and/or nucleic acid amplification test; 3.Signed the informed consent voluntarily and accepted to required treatment or follow up.

Exclusion criteria

Exclusion criteria: 1.Confirmed or suspected, solely or combined extra-genital gonorrhea (pharyngeal and/or rectal); 2.Suspected or diagnosed as complex gonorrhea infection, such as chronic pelvic inflammatory disease, epididymis orchitis, arthritis, etc.; 3.Known to need immediate use of other antibiotics, such as syphilis, bacterial vaginosis, trichomonas infection, etc.; 4.Receipted ceftriaxone or spectinomycin in previously 30 days; 5.People are known to be allergic to ceftriaxone, megamycin, lidocaine or tetracycline drugs, as well as penicillin; 6.In the past one month, drugs that may have adverse drug reactions with the drugs in this study have been used, such as lithium carbonate, vitamin K antagonists, aminoglycosides, etc.; 7.Pregnant and lactating women; 8.People who abuse drugs, drugs or alcohol; 9.HIV antibody positive or receiving pre-exposure/post-exposure antiretroviral therapy; 10.Systematic use of glucocorticoids or other immunosuppressive drugs in the past 1 month; 11.Cytotoxic chemotherapy or radiation therapy within the previous 3 months; 12.Known severe renal or hepatic impairment,with more the 1.5 times of normal ALT or AST,over the up-limit of the urea nitrogen and creatinine; 13.Patients suffering from neuropathy, epilepsy, severe agranulocytopia or severe endocrine diseases; 14.Have or intend to participate in the clinical experiment of other drugs within the last 1 month or within 1 month after starting to use the drug in this study.

Design outcomes

Primary

MeasureTime frame
criteria for evaluation of etiological efficacy;

Secondary

MeasureTime frame
clinical resolution of symptoms;

Countries

China

Contacts

Public ContactSu Xiaohong

Dermatology Hospital, Chinese Academy of Medical Sciences

wslisai@163.com+86 25 85478090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026