Study on Ceftazidime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection (CAZ-SBT)
|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.
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|