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

A Study Evaluating Efficacy and Safety of Ceftriaxone Sodium and Sulbactam Sodium for Injection in the Treatment of Uncomplicated Urogenital Gonorrhea

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.

Study Overview

• Status: Completed
• Conditions: Gonorrhea
• Intervention / Treatment: Drug: Ceftriaxone sodium and Sulbactam Sodium for injection

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 Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ceftriaxone sodium and Sulbactam Sodium for injection; combinations of β-Lactamase inhibitors	Drug: Ceftriaxone sodium and Sulbactam Sodium for injection; Ceftriaxone sodium and Sulbactam Sodium for injection is available as sterile powder for reconstitution.It will be administered as one 3g IV dose for adult or one 75mg/kg IV dose for children under 12.; Other Names: CRO-SBT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: pingyu P Zhou, Doctor, Shanghai Dermatology Hospital; Principal Investigator: shunming S Xu, Doctor, People's Hospital of Shanghai Pudong New Area; Principal Investigator: yanyue Tong, Doctor, People's Hospital of Quzhou; Principal Investigator: zhehu Jin, Doctor, The Affiliated Hospital of Yanbian University; Principal Investigator: bo Cheng, Doctor, First Affiliated Hospital of Fujian Medical University; Principal Investigator: wuqing W Wang, Doctor, The Central Hospital of Shanghai Minhang District; Principal Investigator: ping Wang, Doctor, The Third People's Hospital of Hangzhou

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2015
• Primary Completion (Actual): May 3, 2016
• Study Completion (Actual): May 30, 2016

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 15, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 15, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Gonorrhea; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Ceftriaxone; Sulbactam
• Other Study ID Numbers: GC0048-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No