Status:
COMPLETED
Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus
Lead Sponsor:
PolyMedix, Inc.
Conditions:
Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA)
(Susceptible or Methicillin Resistant)
Eligibility:
All Genders
18-84 years
Phase:
PHASE2
Brief Summary
The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
Eligibility Criteria
Inclusion
- Have a diagnosis of ABSSSI in which S. aureus is clinically suspected to be the likely pathogen
- Clinical manifestation of subjects' ABSSSI must include the presence of purulent material suitable for microbiologic culture, Gram stain examination and PCR assay.
- 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.
- 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
- Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study.
- History of peripheral neuropathy of any form or etiology
- Anticipated need for prolonged antibiotic therapy (i.e., \>8 days)
- ABSSSI known or suspected to be caused exclusively by Gram negative pathogens or anaerobes (both Gram positive or Gram negative)
- Diabetic foot infection: defined as a subacute or chronic infection (\> 4 weeks) below the ankle in a patient with diabetic neuropathy
- Infected burns
- Known infection with human immunodeficiency virus (HIV) and a CD4 count \< 200/mm3
- Active hepatitis B or hepatitis C receiving treatment with interferon or other immunosuppressive therapy
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT01211470
Start Date
October 1 2010
End Date
March 1 2012
Last Update
May 17 2012
Active Locations (8)
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1
Hamilton, Ontario, Canada, L8N 4A6
2
Chicoutimi, Quebec, Canada, G7H 5H6
3
Greenfield Park, Quebec, Canada, J4V 2H1
4
Québec, Quebec, Canada, G1V 4X7