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

Phase 4

Completed

• Conditions: Gonorrhea
• Interventions: Drug: Ceftriaxone sodium and Sulbactam Sodium for injection

• Registration Number: NCT04202068
• Lead Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd

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.

Study Timeline

• Study Start: 2015-07-03
• Primary Completion: 2016-05-03
• Study Completion: 2016-05-30
• Status Verified: 2019-12
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-15
• Last Update Submitted: 2019-12-15
• Study First Posted: 2019-12-17
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ceftriaxone sodium and Sulbactam Sodium for injection	Ceftriaxone sodium and Sulbactam Sodium for injection	combinations of β-Lactamase inhibitors

Primary Outcome Measures

Name	Time	Method
bacterial eradicatio	Up to Day 8	Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site at the Test-of-Cure (TOC)

Secondary Outcome Measures

Name	Time	Method
clinical cure	Up to Day 8	Number of subjects with disappearance of clinical symptoms and signs at the Test-of-Cure (TOC)
Comprehensive curative effect	Up to Day 8	Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site and disappearance of clinical symptoms and signs