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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Urinary Tract Infections in Children
• Intervention / Treatment: Drug: Ceftriaxone Sodium and Sulbactam Sodium for Injection

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CRO-SBT; Ceftriaxone Sodium and Sulbactam Sodium for Injection(2:1)	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; Other Names: weipufen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cure rate of patients	Clinically effective/Clinically ineffective	Seven days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bacterial clearance rate	end of treatment of bacteriological efficacy (bacterial clearance rate)	48 hours after treatment

Collaborators and Investigators

• Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: yuhua hu, Doctor, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2015
• Primary Completion (ACTUAL): June 11, 2016
• Study Completion (ACTUAL): May 27, 2017

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (ACTUAL): August 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Respiratory Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Ceftriaxone; Sulbactam
• Other Study ID Numbers: LENVOCRO (2012)CSSSI-0.4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No