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

NCT01897831 | Unknown Phase 4 DMC

• 1 other identifier: 2002 H L 0153
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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 under the widely used in clinical conditions.

Conditions

Respiratory Tract Infections; Urinary Tract Infections

Keywords

Piperacillin Sodium and sulbactam sodium; Phase IV clinical studies; Respiratory and urinary tract infections

Outcome Measures

Primary Outcomes (1)

• overall effect

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

  two year

Secondary Outcomes (1)

• Number of participants with Adverse Events

  two year

Study Arms (1)

xin te mie

EXPERIMENTAL

1.5-3.0g,iv,bid or tid for 7-14 days

Drug: xin te mie

Interventions

xin te mie DRUG

durg:Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) 1.5-3.0g,iv,bid for 7-14 days Serious infections:6.0-12.0g,iv,tid for 7-14 days

Also known as: te mie jun, xin ke jun

xin te mie

Eligibility Criteria

• Age: 18 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

MeSH Terms

Conditions

Respiratory Tract Infections; Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• changqing cq li, doctor

  Chongqing Red Cross Hospital

  STUDY DIRECTOR

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: June 3, 2013
• First Posted: July 12, 2013
• Study Start: August 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 12, 2013

Record last verified: 2012-09