Overview

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

Status:
Completed

Trial end date:
2012-03-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

PolyMedix, Inc.

Treatments:

Daptomycin

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