Complicated Skin and Skin Structure Infections - Tabular View

Tracking Information
First Received Date ^ICMJE	February 6, 2008
Last Updated Date	February 20, 2008
Start Date ^ICMJE	February 2001
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 20, 2008)	The primary measure is clinical response after all antibacterial treatment is stopped). [ Time Frame: 7-28 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00619710 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 20, 2008)	clinical and microbiological response [ Time Frame: Twice 3-28 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Complicated Skin and Skin Structure Infections
Official Title ^ICMJE	A Multicenter, Randomized, Double Blind, Comparative Trial of Intravenous MERREM (Meropenem, ICI 194,660) vs PRIMAXIN I.V. (Imipenem-Cilastatin) in the Treatment of Hospitalised Subjects With Complicated Skin and Skin Structure Infections.
Brief Summary	The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Skin Infection Abscess Cellulitis
Intervention ^ICMJE	Drug: Meropenem Drug: Imipenem-cilastatin
Study Arms / Comparison Groups	Experimental: Meropenem Active Comparator: Imipenem-cilastatin
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	1000
Completion Date	April 2004
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections Within 72 hours before enrollment or at the time of enrollment, all subjects must provide an appropriate specimen for culture and susceptibility testing Subjects who have been given prior antibacterial therapy within 14 days of trial entry may be entered only if a culture is obtained showing persistence of a pathogen in blood or at the site of infection Exclusion Criteria: Subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or carbapenems Subjects with a history of seizure disorders or subjects currently receiving antiepileptic medication Subjects with underlying infections or conditions which would interfere with evaluation of this study
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00619710
Responsible Party
Study ID Numbers ^ICMJE	3591IL/0079, D9211C00079
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	AstraZeneca
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP