Comparative Study of NXL104/ceftazidime versus comparator in adults with complicated urinary tract infections
Study identifier:NXL104/2001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Prospective, multicenter, investigator-blinded, randomized, comparative study estimate safety, tolerability, efficacy of NXL104/ceftazidime vs. comparator followed appropriate oral therapy treatment complicated UTI hosp adults
Medical condition
Complicated urinary tract infection
Phase
Phase 2
Healthy volunteers
No
Study drug
NXL104/ceftazidime, Imipenem/Cilastatin
Sex
All
Actual Enrollment
137
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Nov 2008
Primary Completion Date: 01 Jun 2010
Study Completion Date: 01 Jul 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2011 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 NXL/104 ceftazidime | Drug: NXL104/ceftazidime 125mg/500mg TID Drug: NXL104/ceftazidime 125mg/500mg TID |
| Active Comparator: 2 comparator 4 x daily | Drug: Imipenem/Cilastatin 4 x daily |
Contacts
Investigators
Principal Investigator
Carole A Sable
Novexel Inc
