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

NCT ID: NCT04066621

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-28
• Study Completion Date: 2017-05-27

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.

Conditions

Respiratory Tract Infections; Urinary Tract Infections in Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRO-SBT

Ceftriaxone Sodium and Sulbactam Sodium for Injection(2:1)

Group Type: EXPERIMENTAL

Ceftriaxone Sodium and Sulbactam Sodium for Injection

Intervention Type: DRUG

daily dose was 75 mg/kg by weight, 1-2 times ivgtt per day, 4 to 14 days

Interventions

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

Intervention Type: DRUG

Other Intervention Names

weipufen

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangbei Welman Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yuhua hu, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Other Identifiers

LENVOCRO (2012)CSSSI-0.4

Identifier Type: -

Identifier Source: org_study_id