Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection

NCT01760109 | Completed Phase 4 DMC

• 1 other identifier: 2002HL0153
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin 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; Piperacillin Sodium and Sulbactam Sodium for Injection (2:1); Phase IV

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 (1)

Piperacillin Sodium and Sulbactam Sodium

EXPERIMENTAL

Drug:xintemie 1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days

Drug: Piperacillin Sodium and Sulbactam Sodium

Interventions

Piperacillin Sodium and Sulbactam Sodium DRUG

1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days

Also known as: xin te mie, te mie jun, xin ke jun

Piperacillin Sodium and Sulbactam Sodium

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.
• Age\>18 years old, Gender: both
• Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
• patients were volunteers and signed informed consent form;
• patients did not participate in other clinical trials.

You may not qualify if:

• Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
• Pregnant and Lactating women
• Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
• Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.

Sponsors & Collaborators

• Xiangbei Welman Pharmaceutical Co., Ltd: lead

Study Sites (1)

Chongqing Red Cross hospital

Chongqing, 400020, China

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Urinary Tract Infections

Interventions

Piperacillin; 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)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Changqing Li, doctor

  Chongqing Red Cross Hospital

  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: December 19, 2012
• First Posted: January 3, 2013
• Study Start: July 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

CN (1)