Trial | NCT01211470  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    215
The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
Study Started
Oct 31
2010
Primary Completion
Dec 31
2011
Study Completion
Mar 31
2012
Last Update
May 17
2012
Estimate

Drug Daptomycin

Active Comparator: Daptomycin.

Drug PMX-30063-investigational drug

Experimental: PMX-30063

PMX-30063 Experimental

3 arms of PMX-300063

Daptomycin. Active Comparator

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

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted