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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211470
First Posted: September 29, 2010
Last Update Posted: May 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PolyMedix, Inc.
September 27, 2010
September 29, 2010
May 17, 2012
October 2010
December 2011   (Final data collection date for primary outcome measure)
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.

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 measure of efficacy will be bacteriologic eradication at at end of treatment (day 7/8) of S. aureus (either Methicillin-susceptible Staphylococcus aureus (MSSA) or Methicillin-resistant Staphylococcus aureus (MRSA)) in subjects with ABSSSI and having S. aureus isolated from an appropriate infection site prior to randomization. A positive signal of efficacy will justify further development of this new class of antibiotic, which has no cross resistance to other classes of antimicrobials.
Complete list of historical versions of study NCT01211470 on ClinicalTrials.gov Archive Site
Not Provided
  • Clinical response [ Time Frame: response at 48-72 hour ]
    To assess early clinical response at 48-72 hour using objective data including precise dimensions of infection site, changes in temperature and leukocytosis, and photographic evidence of inflammation (purulence, erythema and induration).
  • Evaluate the safety and pharmacokinetics of PMX-30063 [ Time Frame: Immediately after the end of the first infusion (peak) and immediately before the start and after the end of the 3rd and 5th infusions . ]
    To further evaluate the safety of PMX-30063 in the enrolled patients and the pharmacokinetic factors (peak and trough levels) that may influence patient safety. days at 2, 6, and 12 hours after the end of the study drug infusion.
Not Provided
Not Provided
 
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
The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA)
  • (Susceptible or Methicillin Resistant)
  • Drug: Daptomycin
    Active Comparator: Daptomycin.
  • Drug: PMX-30063-investigational drug
    Experimental: PMX-30063
  • Experimental: PMX-30063
    3 arms of PMX-300063
    Intervention: Drug: PMX-30063-investigational drug
  • Active Comparator: Daptomycin.
    Daptomycin will be administered according to the approved product monograph information for ABSSSI.
    Intervention: Drug: Daptomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
March 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 84 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Russian Federation,   Ukraine
 
 
NCT01211470
PROTOCOL PMX63-203
Yes
Not Provided
Not Provided
PolyMedix, Inc.
PolyMedix, Inc.
Not Provided
Not Provided
PolyMedix, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP