NCT04066621

PHase IV Clinical Trial of Ceftriaxone Sodium and Sulbactam Sodium for Injection (CRO-SBT)

Efficacy and Safety of CRO-SBT Performed in Children With Acute Bacterial Infection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of treatment of children with acute bacterial infection disease with Ceftriaxone Sodium and Sulbactam Sodium for Injection in the condition of widely used, and provide the basis of adjusting the dosage regimen for children in particular.

Detailed description

Ceftriaxone sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis，the latter making irreversible competitive inhibition of β-lactamase.The antimicrobial effect of Ceftriaxone can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Ceftriaxone in the treatment-resistant pathogen infections.

Conditions

• Respiratory Tract Infections
• Urinary Tract Infections in Children

Interventions

Type	Name	Description
DRUG	Ceftriaxone Sodium and Sulbactam Sodium for Injection	daily dose was 75 mg/kg by weight, 1-2 times ivgtt per day, 4 to 14 days

Timeline

• Start date: 2015-04-28
• Primary completion: 2016-06-11
• Completion: 2017-05-27
• First posted: 2019-08-26
• Last updated: 2019-08-28