Study on Ceftazidime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection (CAZ-SBT)
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|ClinicalTrials.gov Identifier: NCT01601093|
Recruitment Status : Unknown
Verified April 2012 by Xiangbei Welman Pharmaceutical Co., Ltd.
Recruitment status was: Recruiting
First Posted : May 17, 2012
Last Update Posted : June 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Tract Infections Urinary Tract Infections||Drug: High dose Drug: Low dose Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||288 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Phase Ⅱ Study on Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||November 2013|
Experimental: High dose
Drug: High dose
Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.
Other Name: high dose group
Experimental: Low dose
Drug: Low dose
Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.
Active Comparator: CFP/SUB
Cefoperazone and sulbactam sodium for injection(2:1)
Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)
Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.
Other Name: CFP/SUB(2:1)
- The rate of bacterial clearance [ Time Frame: two years ]end of treatment of bacteriological efficacy(bactercial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs
- Number of participants with Adverse Events [ Time Frame: two years ]the incidence(%)of allergies, skin rashes, shock,death, etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601093
|Contact: ting wt wang, email@example.com|
|Contact: yaowen yw lu, firstname.lastname@example.org|
|the First Affiliated Hospital With Medical University||Recruiting|
|Nanjing, Jiangsu, China|
|Contact: hong wh wang, doctor 025-83714511 ext 6360|
|Sub-Investigator: mao hm huang, doctor|
|Principal Investigator:||hong wh wang, doctor||The first affliated hospital with Nanjing Medical University|