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

Primary Purpose

Respiratory Tract Infections, Urinary Tract Infections in Children

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ceftriaxone Sodium and Sulbactam Sodium for Injection
Sponsored by
Xiangbei Welman Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Tract Infections

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CRO-SBT

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    The cure rate of patients
    Clinically effective/Clinically ineffective

    Secondary Outcome Measures

    bacterial clearance rate
    end of treatment of bacteriological efficacy (bacterial clearance rate)

    Full Information

    First Posted
    August 22, 2019
    Last Updated
    August 26, 2019
    Sponsor
    Xiangbei Welman Pharmaceutical Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04066621
    Brief Title
    PHase IV Clinical Trial of Ceftriaxone Sodium and Sulbactam Sodium for Injection (CRO-SBT)
    Acronym
    CRO-SBT
    Official Title
    Efficacy and Safety of CRO-SBT Performed in Children With Acute Bacterial Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 28, 2015 (Actual)
    Primary Completion Date
    June 11, 2016 (Actual)
    Study Completion Date
    May 27, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xiangbei Welman Pharmaceutical Co., Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Tract Infections, Urinary Tract Infections in Children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CRO-SBT
    Arm Type
    Experimental
    Arm Description
    Ceftriaxone Sodium and Sulbactam Sodium for Injection(2:1)
    Intervention Type
    Drug
    Intervention Name(s)
    Ceftriaxone Sodium and Sulbactam Sodium for Injection
    Other Intervention Name(s)
    weipufen
    Intervention Description
    daily dose was 75 mg/kg by weight, 1-2 times ivgtt per day, 4 to 14 days
    Primary Outcome Measure Information:
    Title
    The cure rate of patients
    Description
    Clinically effective/Clinically ineffective
    Time Frame
    Seven days after treatment
    Secondary Outcome Measure Information:
    Title
    bacterial clearance rate
    Description
    end of treatment of bacteriological efficacy (bacterial clearance rate)
    Time Frame
    48 hours after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    yuhua hu, Doctor
    Organizational Affiliation
    The First Affiliated Hospital with Nanjing Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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