Complicated Skin and Skin Structure Infections

Cellulitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619710
• Other study ID #: 3591IL/0079
• Secondary ID: D9211C00079
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2008
• Last updated: August 31, 2017
• Start date: February 2001
• Est. completion date: April 2004

Study information

• Verified date: August 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 2004
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Cellulitis
• Communicable Diseases
• Infection
• Skin Diseases, Infectious
• Skin Infection

Intervention

Drug:
• Meropenem
Intravenous
• Imipenem-cilastatin
Intravenous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary measure is clinical response after all antibacterial treatment is stopped).		7-28 days
Secondary	clinical and microbiological response		Twice 3-28 days