Complicated Skin and Skin Structure Infections

NCT00619710 | Completed Phase 3

• 2 other identifiers: 3591IL/0079D9211C00079
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Skin Infection; Abscess; Cellulitis

Keywords

skin infections; MERREM; PRIMAXIN IV; complex abscess; perirectal abscess; wound infections; infected ischemic/diabetic ulcers; cellulitis; Meropenem; Imipenem-cilastatin

Outcome Measures

Primary Outcomes (1)

• The primary measure is clinical response after all antibacterial treatment is stopped).

  7-28 days

Secondary Outcomes (1)

• clinical and microbiological response

  Twice 3-28 days

Study Arms (2)

1

EXPERIMENTAL

Meropenem

Drug: Meropenem

2

ACTIVE COMPARATOR

Imipenem-cilastatin

Drug: Imipenem-cilastatin

Interventions

Meropenem DRUG

Intravenous

Also known as: Merrem

1

Imipenem-cilastatin DRUG

Intravenous

Also known as: Primaxin

2

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Cellulitis; Abscess; Wound Infection

Interventions

Meropenem; Cilastatin, Imipenem Drug Combination

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imipenem; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2001
• Primary Completion: December 1, 2003
• Study Completion: April 1, 2004
• Last Updated: September 1, 2017

Record last verified: 2017-08