Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Complicated Skin and Skin Structure Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00619710
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : September 1, 2017
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Skin Infection Abscess Cellulitis Drug: Meropenem Drug: Imipenem-cilastatin Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : February 2001
Actual Primary Completion Date : December 2003
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Meropenem
Drug: Meropenem
Intravenous
Other Name: Merrem

Active Comparator: 2
Imipenem-cilastatin
Drug: Imipenem-cilastatin
Intravenous
Other Name: Primaxin




Primary Outcome Measures :
  1. The primary measure is clinical response after all antibacterial treatment is stopped). [ Time Frame: 7-28 days ]

Secondary Outcome Measures :
  1. clinical and microbiological response [ Time Frame: Twice 3-28 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00619710    
Other Study ID Numbers: 3591IL/0079
D9211C00079
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Keywords provided by Pfizer:
skin infections
MERREM
PRIMAXIN IV
complex abscess
perirectal abscess
wound infections
infected ischemic/diabetic ulcers
cellulitis
Meropenem
Imipenem-cilastatin
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Abscess
Cellulitis
Skin Diseases, Infectious
Suppuration
Inflammation
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Meropenem
Imipenem
Cilastatin, Imipenem Drug Combination
Cilastatin
Anti-Bacterial Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action