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

NCT ID: NCT01211470

Last Updated: 2012-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-03-31

Brief Summary

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PMX-30063

3 arms of PMX-300063

Group Type: EXPERIMENTAL

PMX-30063-investigational drug

Intervention Type: DRUG

Experimental: PMX-30063

Daptomycin.

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

Group Type: ACTIVE_COMPARATOR

Daptomycin

Intervention Type: DRUG

Active Comparator: Daptomycin.

Interventions

Daptomycin

Active Comparator: Daptomycin.

Intervention Type: DRUG

PMX-30063-investigational drug

Experimental: PMX-30063

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PolyMedix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hamilton, Ontario, Canada

Chicoutimi, Quebec, Canada

Greenfield Park, Quebec, Canada

Québec, Quebec, Canada

Sherbrooke, Quebec, Canada

Trois-Rivières, Quebec, Canada

11 Sites

Multiple, , Russia

5 Sites

Multiple, , Ukraine

Countries

Canada; Russia; Ukraine

Other Identifiers

PROTOCOL PMX63-203

Identifier Type: -

Identifier Source: org_study_id