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Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections

Information source: Cempra Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin Diseases, Bacterial

Intervention: CEM-102 (Drug); Linezolid (Drug); CEM-102 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Cempra Pharmaceuticals

Summary

The purpose of this study is to determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).

Clinical Details

Official title: A Phase 2, Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of CEM-102 Compared to Linezolid in the Treatment of Acute Bacterial Skin Structure Infections

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population

Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population

Secondary outcome:

Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population

Clinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population

Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population

Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population

Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population

Clinical Success at test of cure (TOC) for the microbiologically evaluable (ME) population

Clinical success at the test of cure (TOC) by baseline pathogen for the microbiological intent-to-treat (MITT) population

Clinical success at test of cure (TOC) by baseline pathogen for the microbiologically evaluable (ME) population

By-pathogen microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population

By-pathogen microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population

By-patient microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population

By-patient microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population

Detailed description: ABSSIs are common and affect all age groups. In recent years, ABSSIs caused by multi-drug resistant pathogens, especially methicillin-resistant Staphylococcus aureus (MRSA) have become more common. There is an urgent need for additional antibacterial drugs with modes of action different from those currently available. CEM-102 is one such agent with excellent activity against S. aureus, including MRSA.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days

duration which was suspected or proven to be caused, at least in part, by a gram-positive pathogen.

- Eligible infections included cellulitis measuring at least 10 cm length and width or

100 cm squared, with or without a focal abscess, and surgical or traumatic wound infections

- Infection which in the opinion of the investigator will require 10-14 days of

antibacterial therapy.

- Have at least 3 of the following local and/or systemic symptoms and/or signs of

infection: purulent or seropurulent drainage/discharge, erythema, fluctuance, heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional lymph node swelling or tenderness, temperature >=100. 4 degree F, increased white blood cell count, or bandemia.

- Must not have received treatment with another systemic antibiotic for the current

ABSSI. Exclusion Criteria:

- Superficial skin structure infections such as folliculitis, carbuncles, furunculosis,

cutaneous abscesses, and simple cellulitis.

- Infections involving burns, human or animal bites, or chronic diabetic foot ulcers.

- Suspected polymicrobial infection involving Pseudomonas aeruginosa

- Anticipated need for >14 days of antibiotic therapy.

- Infections complicated by the presence of prosthetic materials that will not be

removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement prosthesis.

- Known significant renal, hepatic, or hematologic impairment.

- Received prior potentially effective antimicrobial therapy for the acute bacterial

skin and skin structure infection, unless they were failing therapy after 48 hours or had a gram-positive pathogen non-susceptible to prior therapy identified as a causative pathogen.

Locations and Contacts

Chula Vista, California 91911, United States

La Mesa, California 91942, United States

Los Angeles, California 90015, United States

Oceanside, California 92056, United States

Oxnard, California 93030, United States

Pasadena, California 91105, United States

Santa Ana, California 92701, United States

Torrance, California 90501, United States

Torrance, California 90509, United States

Columbus, Georgia 31904, United States

Savannah, Georgia 31406, United States

Springfield, Illinois 62701, United States

Detroit, Michigan 48202, United States

Butte, Montana 59701, United States

Somers Point, New Jersey 08244, United States

Akron, Ohio 44304, United States

Additional Information

Starting date: August 2009
Last updated: September 15, 2011

Page last updated: August 23, 2015

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