Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
Study NCT ID:
NCT04202068
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2019-12-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating Efficacy and Safety of CRO-SBT in the Treatment of Gonorrhea
Sponsor:
Xiangbei Welman Pharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
A Study Evaluating Efficacy and Safety of Ceftriaxone Sodium and Sulbactam Sodium for Injection in the Treatment of Uncomplicated Urogenital Gonorrhea
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRO-SBT
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: