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

PolyMedix

Status and phase: Completed; Phase 2

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

Treatments: Drug: PMX-30063-investigational drug; Drug: Daptomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211470

PROTOCOL PMX63-203

Details and patient eligibility

About

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

Enrollment: 215 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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215 participants in 2 patient groups

PMX-30063

Experimental group

Description:

3 arms of PMX-300063

Treatment:

Drug: PMX-30063-investigational drug

Daptomycin.

Active Comparator group

Description:

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

Treatment:

Drug: Daptomycin