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

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ClinicalTrials.gov Identifier: NCT04066621
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Urinary Tract Infections in Children Drug: Ceftriaxone Sodium and Sulbactam Sodium for Injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of CRO-SBT Performed in Children With Acute Bacterial Infection
Actual Study Start Date : April 28, 2015
Actual Primary Completion Date : June 11, 2016
Actual Study Completion Date : May 27, 2017

Resource links provided by the National Library of Medicine


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 Name: weipufen




Primary Outcome Measures :
  1. The cure rate of patients [ Time Frame: Seven days after treatment ]
    Clinically effective/Clinically ineffective


Secondary Outcome Measures :
  1. bacterial clearance rate [ Time Frame: 48 hours after treatment ]
    end of treatment of bacteriological efficacy (bacterial clearance rate)



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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066621


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

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Responsible Party: Xiangbei Welman Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT04066621     History of Changes
Other Study ID Numbers: LENVOCRO (2012)CSSSI-0.4
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Respiratory Tract Infections
Urologic Diseases
Respiratory Tract Diseases
Ceftriaxone
Sulbactam
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action