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

NCT ID: NCT01897831

Last Updated: 2013-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Piperacillin sodium and sulbactam sodium for injection (2:1) plays a therapeutic role by the former inhibiting bacterial cell wall synthesis by irreversible competitive inhibition of β-lactamase. The antimicrobial effect of cefotaxime can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Piperacillin in the treatment-resistant pathogen infections.

Conditions

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Respiratory Tract Infections Urinary Tract Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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xin te mie

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

Group Type EXPERIMENTAL

xin te mie

Intervention Type 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

Interventions

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xin te mie

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

Intervention Type DRUG

Other Intervention Names

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te mie jun xin ke jun

Eligibility Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangbei Welman Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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changqing cq li, doctor

Role: STUDY_DIRECTOR

Chongqing Red Cross Hospital

Other Identifiers

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2002 H L 0153

Identifier Type: -

Identifier Source: org_study_id

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