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

NCT01601093 | Suspended Phase 2 DMC

• 1 other identifier: 2008L03354
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections; Urinary Tract Infections

Keywords

Respiratory and urinary tract infections; Ceftazidime and Sulbactam Sodium for Injection (2:1); Phase Ⅱ

Outcome Measures

Primary Outcomes (1)

• The rate of bacterial clearance

  end of treatment of bacteriological efficacy(bactercial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs

  two years

Secondary Outcomes (1)

• Number of participants with Adverse Events

  two years

Study Arms (3)

High dose

EXPERIMENTAL

Ceftazidime 3g

Drug: High dose

Low dose

EXPERIMENTAL

Ceftazidime 2g

Drug: Low dose

CFP/SUB

ACTIVE COMPARATOR

Cefoperazone and sulbactam sodium for injection(2:1)

Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)

Interventions

High dose DRUG

Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.

Also known as: high dose group

High dose

Low dose DRUG

Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.

Low dose

Cefoperazone and Sulbactam Sodium (CFP/SUB) DRUG

Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.

Also known as: CFP/SUB(2:1)

CFP/SUB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
• Hospital patients or good compliance clinic patients, who were more than 18 years old and less than 70 years old, Gender: both.
• Patients who do not take other antibiotic medications before screening period.
• 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)
• Pathogenic bacteria was resistant to ceftazidime and sensitive to both of test drugs and contrast drugs.
• Women of childbearing was to be negative pregnancy test and agree to take contraceptive measures during the trial.
• Patients were volunteers and signed informed consent from.

You may not qualify if:

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

Sponsors & Collaborators

• Xiangbei Welman Pharmaceutical Co., Ltd: lead

Study Sites (1)

the First Affiliated Hospital With Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Urinary Tract Infections

Interventions

Population Groups; Contraceptives, Oral; Cefoperazone; Sulbactam

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Cefamandole; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillins

Study Officials

• hong wh wang, doctor

  The first affliated hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 17, 2012
• Study Start: November 1, 2011
• Primary Completion: August 15, 2022
• Study Completion: December 15, 2022
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

CN (1)