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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211470
First Posted: September 29, 2010
Last Update Posted: May 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PolyMedix, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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) ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: PolyMedix, Inc.
ClinicalTrials.gov Identifier: NCT01211470     History of Changes
Other Study ID Numbers: PROTOCOL PMX63-203
First Submitted: September 27, 2010
First Posted: September 29, 2010
Last Update Posted: May 17, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents