A Study Evaluating Efficacy and Safety of CRO-SBT in the Treatment of Gonorrhea

Xiangbei Welman Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Gonorrhea

Treatments

Drug: Ceftriaxone sodium and Sulbactam Sodium for injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT04202068

GC0048-015

Details and patient eligibility

About

This is a phaseIV, multicenter, open-label，single arm study which will be performed to evaluate efficacy and safety of Ceftriaxone sodium and Sulbactam Sodium for injection for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae in adolescent and adult subjects.

Full description

In this study, adults will be administered as one 3g IV dose at the study site,Children under 12 will be administered as one 75mg/kg IV dose . Approximately 100 subjects will be recruited to receive study treatment. The duration of the study will be approximately 14 days.

Enrollment

113 patients

Sex

All

Ages

6 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must be >=6 or ≦80 years of age at the time of signing the informed consent,both gender
Subjects having clinical suspicion of a urogenital gonococcal infection with or without gonococcal infection according to the laboratory test results of symptoms, physical symptoms, gonococcus smear, culture, etc.
Subjects having clinical suspicion of a gonococcal infection must have both of the following risk factors:once used three generations of cephalosporin invalid, and sensitive to this product (including gonorrhea urethritis, cervicitis, proctitis, pharyngitis).
Male and female subject must agree to use contraception (male condoms) during intercourse from the Baseline Visit through completion of the TOC Visit.

Exclusion criteria

Subject has a history of sensitivity to the study treatments, or components thereof, or a history of a drug (including erythromycin and any macrolide or ketolide drug) or other allergy that, in the opinion of the investigator or medical monitor, contraindicates his or her participation
Subject has received any cephalosporinl therapy for the treatment of a gonococcal infection
Pregnant or lactating women, or women Subject of childbearing age who were unwilling or unable to use acceptable methods of contraception throughout the study period.
Famale subject who were positive for pregnancy tests at the time of inclusion or before the start of study drug use.
Subject has risk of potentially serious drug interactions
Subject has major diseases such as cardiovascular disease, hepatorenal disease and mental disease, or other factors, the researcher should not participate in the study according to comprehensive judgment
Subject has a known history of alcohol or drug abuse
Subject has a known any complicated or systemic gonorrhea infection, such as pelvic inflammatory disease, arthritis, endocarditis