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

NCT04202068 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2019-12-17

No results posted yet for this study

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.

Conditions

  • Gonorrhea

Interventions

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.

Sponsors & Collaborators

  • Xiangbei Welman Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • pingyu P Zhou, Doctor · Shanghai Dermatology Hospital

  • shunming S Xu, Doctor · People's Hospital of Shanghai Pudong New Area

  • yanyue Tong, Doctor · People's Hospital of Quzhou

  • zhehu Jin, Doctor · The Affiliated Hospital of Yanbian University

  • bo Cheng, Doctor · First Affiliated Hospital of Fujian Medical University

  • wuqing W Wang, Doctor · The Central Hospital of Shanghai Minhang District

  • ping Wang, Doctor · The Third People's Hospital of Hangzhou

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-03
Primary Completion
2016-05-03
Completion
2016-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04202068 on ClinicalTrials.gov