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

Phase 4

Completed

• Conditions: Respiratory Tract Infections; Urinary Tract Infections in Children
• Interventions: Drug: Ceftriaxone Sodium and Sulbactam Sodium for Injection

• Registration Number: NCT04066621
• Lead Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd

Brief 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.

Study Timeline

• Study Start: 2015-04-28
• Primary Completion: 2016-06-11
• Study Completion: 2017-05-27
• Status Verified: 2019-08
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male or female children ages≥6 years to< 14 years.
• Weight≥18kg who in hospital or outpatients with good compliance;
• The subjects were diagnosed as respiratory infection, urinary tract infection or other infection caused by the compound sensitive bacteria after clinical symptoms and signs laboratory examination and auxiliary examination according to the clinically recognized diagnostic criteria, and should be treated with systemic antibiotics;
• Subjects had not used effective antimicrobial agents before screening, or had used antimicrobial agents but the efficacy was not obvious;
• No severe liver and kidney cardiovascular and hematopoietic diseases were found in the subjects (AST and ALT were not more than 1.5 times of the upper limit of normal value,Cr was within the normal range);
• Subject guardian informed consent and/or subject's own informed consent subject volunteers to participate in this study and has signed the subject's informed consent.

Exclusion Criteria

• History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other β-lactam antibiotics;
• Patients with specific infections who require treatment with other antimicrobial agents;
• Use of penicillin roxithromycin vitamin B vitamin C and other drugs may interfere with the efficacy or safety evaluation of drugs at the same time;
• Patients at risk of serious drug interactions due to combination of medications;
• Patients who have other diseases and thought to affect efficacy evaluations or be poor compliance;
• Attended clinical trial in three monthes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRO-SBT	Ceftriaxone Sodium and Sulbactam Sodium for Injection	Ceftriaxone Sodium and Sulbactam Sodium for Injection(2:1)

Primary Outcome Measures

Name	Time	Method
The cure rate of patients	Seven days after treatment	Clinically effective/Clinically ineffective

Secondary Outcome Measures

Name	Time	Method
bacterial clearance rate	48 hours after treatment	end of treatment of bacteriological efficacy (bacterial clearance rate)