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

Primary Purpose

Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA), (Susceptible or Methicillin Resistant)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Daptomycin
PMX-30063-investigational drug
Sponsored by
PolyMedix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA) focused on measuring MRSA, ABSSSI, Staphylococcus aureus

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 11 Sites
  • 5 Sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PMX-30063

Daptomycin.

Arm Description

3 arms of PMX-300063

Daptomycin will be administered according to the approved product monograph information for ABSSSI.

Outcomes

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).
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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2010
Last Updated
May 16, 2012
Sponsor
PolyMedix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01211470
Brief Title
Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PolyMedix, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA), (Susceptible or Methicillin Resistant)
Keywords
MRSA, ABSSSI, Staphylococcus aureus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PMX-30063
Arm Type
Experimental
Arm Description
3 arms of PMX-300063
Arm Title
Daptomycin.
Arm Type
Active Comparator
Arm Description
Daptomycin will be administered according to the approved product monograph information for ABSSSI.
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Intervention Description
Active Comparator: Daptomycin.
Intervention Type
Drug
Intervention Name(s)
PMX-30063-investigational drug
Intervention Description
Experimental: PMX-30063
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Eradication at end of treatment (day 7/8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of ABSSSI in which S. aureus is clinically suspected to be the likely pathogen Clinical manifestation of subjects' ABSSSI must include the presence of purulent material suitable for microbiologic culture, Gram stain examination and PCR assay. 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. 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: Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study. History of peripheral neuropathy of any form or etiology Anticipated need for prolonged antibiotic therapy (i.e., >8 days) ABSSSI known or suspected to be caused exclusively by Gram negative pathogens or anaerobes (both Gram positive or Gram negative) Diabetic foot infection: defined as a subacute or chronic infection (> 4 weeks) below the ankle in a patient with diabetic neuropathy Infected burns Known infection with human immunodeficiency virus (HIV) and a CD4 count < 200/mm3 Active hepatitis B or hepatitis C receiving treatment with interferon or other immunosuppressive therapy
Facility Information:
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
11 Sites
City
Multiple
Country
Russian Federation
Facility Name
5 Sites
City
Multiple
Country
Ukraine

12. IPD Sharing Statement

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

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