Clinical trial NCT01211470: Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA)
(Susceptible or Methicillin Resistant)
Keywords: MRSA
ABSSSI
Staphylococcus aureus
Lead sponsor: PolyMedix, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-29
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
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).
timeFrame: Eradication at end of treatment (day 7/8)
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Multiple
country: Russian Federation
facility: 11 Sites
city: Multiple
country: Ukraine
facility: 5 Sites
Study officials:
References: