Back to resultsA Study Evaluating Efficacy and Safety of CRO-SBT in the Treatment of Gonorrhea (CRO-SBT)
Primary Purpose
Gonorrhea
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ceftriaxone sodium and Sulbactam Sodium for injection
Sponsored by
About this trial
This is an interventional treatment trial for Gonorrhea
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ceftriaxone sodium and Sulbactam Sodium for injection
Arm Description
combinations of β-Lactamase inhibitors
Outcomes
Primary Outcome Measures
bacterial eradicatio
Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site at the Test-of-Cure (TOC)
Secondary Outcome Measures
clinical cure
Number of subjects with disappearance of clinical symptoms and signs at the Test-of-Cure (TOC)
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
Full Information
NCT ID
NCT04202068
First Posted
December 11, 2019
Last Updated
December 15, 2019
Sponsor
Xiangbei Welman Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04202068
Brief Title
A Study Evaluating Efficacy and Safety of CRO-SBT in the Treatment of Gonorrhea
Acronym
CRO-SBT
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 3, 2015 (Actual)
Primary Completion Date
May 3, 2016 (Actual)
Study Completion Date
May 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangbei Welman Pharmaceutical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Ceftriaxone sodium and Sulbactam Sodium for injection
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ceftriaxone sodium and Sulbactam Sodium for injection
Arm Type
Experimental
Arm Description
combinations of β-Lactamase inhibitors
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone sodium and Sulbactam Sodium for injection
Other Intervention Name(s)
CRO-SBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
bacterial eradicatio
Description
Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site at the Test-of-Cure (TOC)
Time Frame
Up to Day 8
Secondary Outcome Measure Information:
Title
clinical cure
Description
Number of subjects with disappearance of clinical symptoms and signs at the Test-of-Cure (TOC)
Time Frame
Up to Day 8
Title
Comprehensive curative effect
Description
Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site and disappearance of clinical symptoms and signs
Time Frame
Up to Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
pingyu P Zhou, Doctor
Organizational Affiliation
Shanghai Dermatology Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
shunming S Xu, Doctor
Organizational Affiliation
People's Hospital of Shanghai Pudong New Area
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
yanyue Tong, Doctor
Organizational Affiliation
People's Hospital of Quzhou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
zhehu Jin, Doctor
Organizational Affiliation
The Affiliated Hospital of Yanbian University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
bo Cheng, Doctor
Organizational Affiliation
First Affiliated Hospital of Fujian Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
wuqing W Wang, Doctor
Organizational Affiliation
The Central Hospital of Shanghai Minhang District
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ping Wang, Doctor
Organizational Affiliation
The Third People's Hospital of Hangzhou
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study Evaluating Efficacy and Safety of CRO-SBT in the Treatment of Gonorrhea
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