Complicated Skin and Skin Structure Infections - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00619710

Purpose

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.

Condition	Intervention	Phase
Skin Infection Abscess Cellulitis	Drug: Meropenem Drug: Imipenem-cilastatin	Phase III

MedlinePlus related topics: Cellulitis

Drug Information available for: Meropenem Cilastatin Cilastatin sodium Imipenem Imipenem-cilastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary measure is clinical response after all antibacterial treatment is stopped). [ Time Frame: 7-28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

clinical and microbiological response [ Time Frame: Twice 3-28 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	February 2001
Study Completion Date:	April 2004
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Meropenem	Drug: Meropenem Intravenous
2: Active Comparator Imipenem-cilastatin	Drug: Imipenem-cilastatin Intravenous

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	3591IL/0079, D9211C00079
Study First Received:	February 6, 2008
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00619710
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

skin infections
MERREM
PRIMAXIN IV
complex abscess
perirectal abscess

wound infections
infected ischemic/diabetic ulcers
cellulitis
Meropenem
Imipenem-cilastatin

Study placed in the following topic categories:

Skin Diseases
Ulcer
Ischemia
Inflammation
Imipenem
Cellulitis
Skin Diseases, Infectious

Abscess
Meropenem
Cilastatin
Connective Tissue Diseases
Suppuration
Wound Infection

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Pathologic Processes
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Infection
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009