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Completed

NCT Number: NCT01211470

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

daptomycin

Drug

Active Comparator: Daptomycin.

PMX-30063-investigational drug

Drug

Experimental: PMX-30063

Primary outcomes

  1. 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).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

PolyMedix, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 29, 2010
Registry last updated
May 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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