Complicated Skin and Skin Structure Infections - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cellulitis Skin Infections

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

U.S. FDA Resources

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
Experimental: 1 Meropenem	Drug: Meropenem Intravenous Other Name: Merrem
Active Comparator: 2 Imipenem-cilastatin	Drug: Imipenem-cilastatin Intravenous Other Name: Primaxin

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00619710 History of Changes
Other Study ID Numbers:	3591IL/0079, D9211C00079
Study First Received:	February 6, 2008
Last Updated:	February 20, 2008
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

Additional relevant MeSH terms:

Abscess
Cellulitis
Skin Diseases, Infectious
Suppuration
Infection
Inflammation
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Cilastatin

Imipenem
Meropenem
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012