Clinical trial NCT00948142: Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Diseases, Bacterial
Keywords: Acute Bacterial Skin and Skin Struction Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections; MRSA
Lead sponsor: Arrevus Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-29
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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.

Primary outcomes:
measure: Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population
timeFrame: 7 to 14 days after the last dose of study drug
measure: Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population
timeFrame: 7 to 14 days after the last dose of study drug
Secondary outcomes:
measure: Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population
timeFrame: 10-14 days of study drug
measure: Clinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population
timeFrame: 7 to 14 days after the last dose of study drug
measure: Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population
timeFrame: 10-14 days of study drug
measure: Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population
timeFrame: 10-14 days of study drug
measure: Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population
timeFrame: 10-14 days of study drug
measure: Clinical Success at test of cure (TOC) for the microbiologically evaluable (ME) population
timeFrame: 7-14 days after the last dose of study drug
measure: Clinical success at the test of cure (TOC) by baseline pathogen for the microbiological intent-to-treat (MITT) population
timeFrame: 7-14 days after the last dose of study drug
measure: Clinical success at test of cure (TOC) by baseline pathogen for the microbiologically evaluable (ME) population
timeFrame: 7 to 14 days after the last dose of study drug
measure: By-pathogen microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population
timeFrame: 7-14 days after the last dose of study drug
measure: By-pathogen microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population
timeFrame: 7-14 days after the last dose of study drug
measure: By-patient microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population
timeFrame: 7-14 days after the last dose of study drug
measure: By-patient microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population
timeFrame: 7-14 days after the last dose of study drug
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Torrance
country: United States
state: California
city: Columbus
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Springfield
country: United States
state: Illinois
city: Detroit
country: United States
state: Michigan
city: Butte
country: United States
state: Montana
city: Somers Point
country: United States
state: New Jersey
city: Akron
country: United States
state: Ohio
Study officials:
References:
citation: Craft JC, Moriarty SR, Clark K, Scott D, Degenhardt TP, Still JG, Corey GR, Das A, Fernandes P. A randomized, double-blind phase 2 study comparing the efficacy and safety of an oral fusidic acid loading-dose regimen to oral linezolid for the treatment of acute bacterial skin and skin structure infections. Clin Infect Dis. 2011 Jun;52 Suppl 7:S520-6. doi: 10.1093/cid/cir167.