Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus
Information source: PolyMedix, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA); (Susceptible or Methicillin Resistant)
Intervention: Daptomycin (Drug); PMX-30063-investigational drug (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: PolyMedix, Inc.
Summary
The study investigates the safety and efficacy of PMX-30063 in patients treated for acute
bacterial skin and skin-structure infection (ABSSSI).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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).
Eligibility
Minimum age: 18 Years.
Maximum age: 84 Years.
Gender(s): Both.
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
Locations and Contacts
Quebec G1V 4X7, Canada
11 Sites, Multiple, Russian Federation
5 Sites, Multiple, Ukraine
Hamilton, Ontario L8N 4A6, Canada
Chicoutimi, Quebec G7H 5H6, Canada
Greenfield Park, Quebec J4V 2H1, Canada
Sherbrooke, Quebec J1H 5N4, Canada
Trois-Rivieres, Quebec G8Z 3R9, Canada
Additional Information
Starting date: October 2010
Last updated: May 16, 2012
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