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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT01211470 (opens ClinicalTrials.gov in a new tab)Other idPROTOCOL PMX63-203
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
215 participants (actual)
Sponsor
PolyMedix, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
3 countries

Canada, Russia, Ukraine

Start
Oct 2010
Primary completion
Dec 2011
Completion
Mar 2012
First posted
29 Sept 2010 (estimated)
Last update posted
17 May 2012 (estimated)
Conditions
Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA) · (Susceptible or Methicillin Resistant)

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 2

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

    NCT01211470

    Oct 2010 to Mar 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • DaptomycinDrug
  • PMX-30063-investigational drugDrug

Arms2

  • Experimental

    PMX-30063

    3 arms of PMX-300063

  • Active comparator

    Daptomycin.

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  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)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 84 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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