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

Skin Diseases, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948142
• Other study ID #: CE06-300
• Status: Completed
• Phase: Phase 2
• Start date: August 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2019
• Source: Arrevus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• Skin Diseases
• Skin Diseases, Bacterial

Intervention

Drug:
• CEM-102
600 mg BID oral tablets for 10-14 days
• Linezolid
600 mg BID oral tablets
• CEM-102
1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arrevus Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population	Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required	7 to 14 days after the last dose of study drug
Primary	Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population	Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required	7 to 14 days after the last dose of study drug
Secondary	Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population	Meets the following definition for clinical success: Complete resolution of the signs and symptoms of the ABSSI and no further study drug therapy is required.	10-14 days of study drug
Secondary	Clinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population	Meets the following definition for clinical success: Complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.	7 to 14 days after the last dose of study drug
Secondary	Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population	Meets the following definition for clinical success: complete resolution of the signs and symptoms of the ABSSI and no further study drug therapy is required.	10-14 days of study drug
Secondary	Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population	Meets the following definition for clinical success at the end of treatment: complete resolutoin of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required	10-14 days of study drug
Secondary	Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population	Meets the following definition for clinical success: complete resolution of signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.	10-14 days of study drug
Secondary	Clinical Success at test of cure (TOC) for the microbiologically evaluable (ME) population	Meets the following definition of clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.	7-14 days after the last dose of study drug
Secondary	Clinical success at the test of cure (TOC) by baseline pathogen for the microbiological intent-to-treat (MITT) population	Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additonal systemic antibacterial therapy is required	7-14 days after the last dose of study drug
Secondary	Clinical success at test of cure (TOC) by baseline pathogen for the microbiologically evaluable (ME) population	Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required	7 to 14 days after the last dose of study drug
Secondary	By-pathogen microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population	Successful responses included: eradication: the basline causative pathogen was absent from the culture(s) presumed eradication: the patient's clincial response was success, and no culture available.	7-14 days after the last dose of study drug
Secondary	By-pathogen microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population	Successful responses included: eradication: the basline causative pathogen was absent from the culture(s) presumed eradication: the patient's clincial response was success, and no culture available.	7-14 days after the last dose of study drug
Secondary	By-patient microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population	Successful responses included: eradication: the baseline causative organisms have a response of eradication. presumed eradication: all baseline causative organism(s) have a response of presumed eradication combined eradication/presumed eradication: in cases where baseline causative organisms were from a blood and an ABSSI culture	7-14 days after the last dose of study drug
Secondary	By-patient microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population	Successful responses included: eradication: the baseline causative organisms have a response of eradication. presumed eradication: all baseline causative organism(s) have a response of presumed eradication combined eradication/presumed eradication: in cases where baseline causative organisms were from a blood and an ABSSI culture	7-14 days after the last dose of study drug