Trial | NCT04202068  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    113
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.
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 Started
Jul 03
2015
Primary Completion
May 03
2016
Study Completion
May 30
2016
Last Update
Dec 17
2019

Drug Ceftriaxone sodium and Sulbactam Sodium for injection [ceftriaxone (rocephin), sulbactam (unasyn)]

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

Ceftriaxone sodium and Sulbactam Sodium for injection Experimental

combinations of β-Lactamase inhibitors

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
No Results Posted