Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PolyMedix, Inc.
ClinicalTrials.gov Identifier:
NCT01211470
First received: September 27, 2010
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).


Condition Intervention Phase
Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA)
(Susceptible or Methicillin Resistant)
Drug: Daptomycin
Drug: PMX-30063-investigational drug
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Dose Ranging, Active Controlled Efficacy and Safety Evaluation of PMX-30063 As Initial Treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Caused by Staphylococcus Aureus

Resource links provided by NLM:


Further study details as provided by PolyMedix, Inc.:

Primary Outcome Measures:
  • The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI). [ Time Frame: Eradication at end of treatment (day 7/8) ] [ Designated as safety issue: No ]

    The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI). The primary measure of efficacy will be bacteriologic eradication at end of treatment of S. aureus (either Methicillin-susceptible (MSSA) or Methicillin-resistant (MRSA)) in subjects with ABSSSI and having S. aureus isolated from an appropriate infection site prior to randomization.

    The secondary objectives are clinical responses, safety and pharokinetics of PMX-300063.



Enrollment: 215
Study Start Date: October 2010
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PMX-30063
3 arms of PMX-300063
Drug: PMX-30063-investigational drug
Experimental: PMX-30063
Active Comparator: Daptomycin.
Daptomycin will be administered according to the approved product monograph information for ABSSSI.
Drug: Daptomycin
Active Comparator: Daptomycin.

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a diagnosis of ABSSSI in which S. aureus is clinically suspected to be the likely pathogen
  2. Clinical manifestation of subjects' ABSSSI must include the presence of purulent material suitable for microbiologic culture, Gram stain examination and PCR assay.
  3. The ABSSSI must be 75 cm2 or greater in size in order for the subject to be eligible for this study. This includes the primary and surrounding erythema, swelling or induration.
  4. Super-infected eczema or other chronic medical conditions (e.g., atopic dermatitis, hidradentitis suppurativa) characterized by prominent signs of inflammation for an extended period even after successful bacterial eradication. (Subjects with an ABSSSI that involves an anatomic location in which there is no evidence of a chronic skin condition are eligible for enrollment.)

Exclusion Criteria:

  1. Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study.
  2. History of peripheral neuropathy of any form or etiology
  3. Anticipated need for prolonged antibiotic therapy (i.e., >8 days)
  4. ABSSSI known or suspected to be caused exclusively by Gram negative pathogens or anaerobes (both Gram positive or Gram negative)
  5. Diabetic foot infection: defined as a subacute or chronic infection (> 4 weeks) below the ankle in a patient with diabetic neuropathy
  6. Infected burns
  7. Known infection with human immunodeficiency virus (HIV) and a CD4 count < 200/mm3
  8. Active hepatitis B or hepatitis C receiving treatment with interferon or other immunosuppressive therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211470

Locations
Canada, Ontario
Hamilton, Ontario, Canada, L8N 4A6
Canada, Quebec
Chicoutimi, Quebec, Canada, G7H 5H6
Greenfield Park, Quebec, Canada, J4V 2H1
Sherbrooke, Quebec, Canada, J1H 5N4
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Canada
Quebec, Canada, G1V 4X7
Russian Federation
11 Sites
Multiple, Russian Federation
Ukraine
5 Sites
Multiple, Ukraine
Sponsors and Collaborators
PolyMedix, Inc.
  More Information

No publications provided

Responsible Party: PolyMedix, Inc.
ClinicalTrials.gov Identifier: NCT01211470     History of Changes
Other Study ID Numbers: PROTOCOL PMX63-203
Study First Received: September 27, 2010
Last Updated: May 16, 2012
Health Authority: Canada: Health Canada

Keywords provided by PolyMedix, Inc.:
MRSA
ABSSSI
Staphylococcus aureus

Additional relevant MeSH terms:
Staphylococcal Infections
Skin Diseases, Bacterial
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Infectious
Infection
Skin Diseases
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014