Clinical trial NCT04202068: A Study Evaluating Efficacy and Safety of CRO-SBT in the Treatment of Gonorrhea
Official title: A Study Evaluating Efficacy and Safety of Ceftriaxone Sodium and Sulbactam Sodium for Injection in the Treatment of Uncomplicated Urogenital Gonorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gonorrhea
Lead sponsor: Xiangbei Welman Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-12-17
Enrollment: 113
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Ceftriaxone sodium and Sulbactam Sodium for injection
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: bacterial eradicatio
timeFrame: Up to Day 8
Secondary outcomes:
measure: clinical cure
timeFrame: Up to Day 8
measure: Comprehensive curative effect
timeFrame: Up to Day 8
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Dermatology Hospital
name: pingyu P Zhou, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Shanghai Pudong New Area
name: shunming S Xu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Quzhou
name: yanyue Tong, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Yanbian University
name: zhehu Jin, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Fujian Medical University
name: bo Cheng, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Central Hospital of Shanghai Minhang District
name: wuqing W Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third People's Hospital of Hangzhou
name: ping Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: