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

NCT01211470 | Completed Phase 2 DMC

• 1 other identifier: PROTOCOL PMX63-203
• Study Type: interventional
• Target: 215
• Locations: 3 countries
• Sites: 8

Brief Summary

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

Conditions

Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA); (Susceptible or Methicillin Resistant)

Keywords

MRSA; ABSSSI; Staphylococcus aureus

Outcome Measures

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).

  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.

  Eradication at end of treatment (day 7/8)

Study Arms (2)

PMX-30063

EXPERIMENTAL

3 arms of PMX-300063

Drug: PMX-30063-investigational drug

Daptomycin.

ACTIVE COMPARATOR

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

Drug: Daptomycin

Interventions

Daptomycin DRUG

Active Comparator: Daptomycin.

Daptomycin.

PMX-30063-investigational drug DRUG

Experimental: PMX-30063

PMX-30063

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• PolyMedix, Inc.: lead

Study Sites (8)

Unknown Facility

Hamilton, Ontario, L8N 4A6, Canada

Location

Unknown Facility

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Unknown Facility

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Unknown Facility

Québec, Quebec, G1V 4X7, Canada

Location

Unknown Facility

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Unknown Facility

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

11 Sites

Multiple, Russia

Location

5 Sites

Multiple, Ukraine

Location

MeSH Terms

Conditions

Disease Susceptibility; Staphylococcal Infections

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 29, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

CA (6); RU (1); UA (1)