Study on Ceftazidime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection

Phase 2

Suspended

• Conditions: Respiratory Tract Infections; Urinary Tract Infections
• Interventions: Drug: High dose; Drug: Low dose; Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)

• Registration Number: NCT01601093
• Lead Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd

Brief Summary

In the proposed study, the investigators plan to evaluate the efficacy and safety of Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.

Detailed Description

Ceftazidime is a third-generation cephalosporins. Ceftazidime 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 ceftazidime can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of ceftazidime in the treatment-resistant pathogen infections.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-17
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05
• Primary Completion: 2022-08-15
• Study Completion: 2022-12-15

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

1. Patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
2. Hospital patients or good compliance clinic patients, who were more than 18 years old and less than 70 years old, Gender: both.
3. Patients who do not take other antibiotic medications before screening period.
4. Patients who have no severe liver, kidney and hematopoietic system of diseases (Both AST and ALT are less than 1.5 times of the upper limit of normal and Cr is in normal range)
5. Pathogenic bacteria was resistant to ceftazidime and sensitive to both of test drugs and contrast drugs.
6. Women of childbearing was to be negative pregnancy test and agree to take contraceptive measures during the trial.
7. Patients were volunteers and signed informed consent from.

Exclusion Criteria

1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
2. Pathogenic bacteria was sensitive to ceftazidime or resistant to ceftazidime,test drugs and control drugs.
3. Patients who need to take other antibiotic medicine because of concurrent infection.
4. Patients who took medicine which affected efficacy evaluations and safety evaluations such as aspirin, indomethacin, phenylbutazone, sulfanilamide, disulfiram and probenecid in the trial.
5. Patients who took risks of severe drug interactions because of drug combination.
6. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
7. Pregnant and Lactating women
8. Drug addicts and alcoholics.
9. Patients who once was selected in this trial.
10. Patients who participated in other clinical trials in the past three months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High dose	High dose	Ceftazidime 3g
Low dose	Low dose	Ceftazidime 2g
CFP/SUB	Cefoperazone and Sulbactam Sodium (CFP/SUB)	Cefoperazone and sulbactam sodium for injection(2:1)

Primary Outcome Measures

Name	Time	Method
The rate of bacterial clearance	two years	end of treatment of bacteriological efficacy(bactercial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs

Secondary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events	two years	the incidence(%)of allergies, skin rashes, shock,death, etc.

Trial Locations

Locations (1)

the First Affiliated Hospital With Medical University; 🇨🇳 Nanjing, Jiangsu, China