Prospective Multicenter Doubleblind Randomized Study of NXL104/ceftazidime + metronidazole vs. meropenem in treatment of complicated intra-abdominal infections
Study identifier:NXL104/2002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to estimate the safety, tolerability and efficacy of NXL104/ceftazidime plus metronidazole vs. meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults
Medical condition
Complicated intra-abdominal infections
Phase
Phase 2
Healthy volunteers
No
Study drug
ceftazidime/NXL104 + metronidazole, meropenem
Sex
All
Actual Enrollment
200
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Mar 2009
Primary Completion Date: 01 Nov 2009
Study Completion Date: 01 Dec 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: NXL104/CAZ/MTZ NXL104/ceftazidime + metronidazole | Drug: ceftazidime/NXL104 + metronidazole IV TID |
| Active Comparator: Meropenem | Drug: meropenem IV TID Other Name: merrem |
