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

NCT ID: NCT04202068

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-03

Study Completion Date

2016-05-30

Brief Summary

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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

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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

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Gonorrhea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Ceftriaxone sodium and Sulbactam Sodium for injection
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ceftriaxone sodium and Sulbactam Sodium for injection

combinations of β-Lactamase inhibitors

Group Type EXPERIMENTAL

Ceftriaxone sodium and Sulbactam Sodium for injection

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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CRO-SBT

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangbei Welman Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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pingyu P Zhou, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Dermatology Hospital

shunming S Xu, Doctor

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Shanghai Pudong New Area

yanyue Tong, Doctor

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Quzhou

zhehu Jin, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Yanbian University

bo Cheng, Doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

wuqing W Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Central Hospital of Shanghai Minhang District

ping Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Third People's Hospital of Hangzhou

Other Identifiers

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GC0048-015

Identifier Type: -

Identifier Source: org_study_id