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

Phase 2

Completed

• Conditions: Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA); (Susceptible or Methicillin Resistant)
• Interventions: Drug: PMX-30063-investigational drug; Drug: Daptomycin

• Registration Number: NCT01211470
• Lead Sponsor: PolyMedix, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Study Start: 2010-10
• Primary Completion: 2011-12
• Study Completion: 2012-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PMX-30063	PMX-30063-investigational drug	3 arms of PMX-300063
Daptomycin.	Daptomycin	Daptomycin will be administered according to the approved product monograph information for ABSSSI.

Primary Outcome Measures

Name	Time	Method
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).	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.

Trial Locations

Locations (2)

11 Sites; 🇷🇺 Multiple, Russian Federation

5 Sites; 🇺🇦 Multiple, Ukraine