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

NCT04066621 | Completed Phase 4

• 1 other identifier: LENVOCRO (2012)CSSSI-0.4
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Tract Infections; Urinary Tract Infections in Children

Outcome Measures

Primary Outcomes (1)

• The cure rate of patients

  Clinically effective/Clinically ineffective

  Seven days after treatment

Secondary Outcomes (1)

• bacterial clearance rate

  48 hours after treatment

Study Arms (1)

CRO-SBT

EXPERIMENTAL

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

Drug: Ceftriaxone Sodium and Sulbactam Sodium for Injection

Interventions

Ceftriaxone Sodium and Sulbactam Sodium for Injection DRUG

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

Also known as: weipufen

CRO-SBT

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangbei Welman Pharmaceutical Co., Ltd: lead

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Ceftriaxone; Sulbactam; Injections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract 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

• yuhua hu, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  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

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 26, 2019
• Study Start: April 28, 2015
• Primary Completion: June 11, 2016
• Study Completion: May 27, 2017
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share