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

NCT04202068 | Completed Phase 4

• 1 other identifier: GC0048-015
• Study Type: interventional
• Target: 113
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gonorrhea

Outcome Measures

Primary Outcomes (1)

• bacterial eradicatio

  Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site at the Test-of-Cure (TOC)

  Up to Day 8

Secondary Outcomes (2)

• clinical cure

  Up to Day 8

• Comprehensive curative effect

  Up to Day 8

Study Arms (1)

Ceftriaxone sodium and Sulbactam Sodium for injection

EXPERIMENTAL

combinations of β-Lactamase inhibitors

Drug: Ceftriaxone sodium and Sulbactam Sodium for injection

Interventions

Ceftriaxone sodium and Sulbactam Sodium for injection 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.

Also known as: CRO-SBT

Ceftriaxone sodium and Sulbactam Sodium for injection

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Xiangbei Welman Pharmaceutical Co., Ltd: lead

MeSH Terms

Conditions

Gonorrhea

Interventions

Ceftriaxone; Sulbactam; Injections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• pingyu P Zhou, Doctor

  Shanghai Dermatology Hospital

  PRINCIPAL INVESTIGATOR

• shunming S Xu, Doctor

  People's Hospital of Shanghai Pudong New Area

  PRINCIPAL INVESTIGATOR

• yanyue Tong, Doctor

  People's Hospital of Quzhou

  PRINCIPAL INVESTIGATOR

• zhehu Jin, Doctor

  The Affiliated Hospital of Yanbian University

  PRINCIPAL INVESTIGATOR

• bo Cheng, Doctor

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• wuqing W Wang, Doctor

  The Central Hospital of Shanghai Minhang District

  PRINCIPAL INVESTIGATOR

• ping Wang, Doctor

  The Third People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ceftriaxone sodium and Sulbactam Sodium for injection

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 17, 2019
• Study Start: July 3, 2015
• Primary Completion: May 3, 2016
• Study Completion: May 30, 2016
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share