NCT04202068

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 6 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gonorrhea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-03
• Primary completion: 2016-05-03
• Completion: 2016-05-30
• First posted: 2019-12-17
• Last updated: 2019-12-17