A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections Due to Staphylococci

NCT01519492 | Completed Phase 2

• 1 other identifier: 12520000-010
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 14

Brief Summary

The purpose of the study is to determine the safety, tolerability and effectiveness of AFN-12520000 for in the treatment of Staphylococcal infections of the skin.

Conditions

Skin and Subcutaneous Tissue Bacterial Infections; Wound Infection; Cutaneous Abscess; Burn Infection; Cellulitis

Keywords

Skin and Subcutaneous Tissue Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Safety

  To assess the safety, tolerability, and efficacy of AFN-12520000 in patients with staphylococcal ABSSSI by exploring a variety of endpoints of clinical response and the rate and type of adverse events from baseline to the long term follow-up.

  From time of consent to long term follow-up (max of 42 days)

Secondary Outcomes (1)

• Pharmacokinetics

  Day 3, Day 5 and at EOT

Study Arms (1)

AFN-12520000

EXPERIMENTAL

100 mg tablet

Drug: AFN-12520000

Interventions

AFN-12520000 DRUG

Two tablets taken in both the morning and evening on an empty stomach for a total daily dose 400 mg

Also known as: AFN-1252, API-1252

AFN-12520000

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent and to understand the demands of the protocol;
• Ages of 18 and 70 years, inclusive;
• Have clinically documented ABSSSI suspected or documented to be caused by staphylococci accompanied by redness, edema, and/or induration of a minimum surface area of 75 cm2 and can be categorized as one or more of the following: Wound infection; Cutaneous abscess Burn infection (≤20% of total body surface area) or Cellulitis
• Have a primary infected lesion with at least three of the following: Significant pain or tenderness to palpation; Purulent or seropurulent drainage or discharge; Erythema; Fluctuance; Induration; Edema; Heat or localized warmth;
• Have at least two of the following signs and symptoms of systemic inflammation or complicating factors: Documented or reported fever \>38.0°C; WBC count of \>10,000 cells/mm3; Greater than 15% immature neutrophils irrespective of total WBC; Elevated CRP or ESR; or Local/regional lymphadenopathy;
• Have a Gram stain with Gram-positive cocci in clusters or PCR result indicating an infection with Staphylococci.
• Have clearly failed as defined in the protocol previous treatment after a minimum of 48 hours
• Women of childbearing potential must have a negative pregnancy test at screening before enrollment
• Male and Female patients must utilize a highly effective method of contraception
• In the judgment of the Investigator have an expectation of survival and prompt improvement with effective oral antibiotic therapy and appropriate supportive care for the anticipated duration of the study
• Willing and able to comply with all the study activities and procedures in the hospital or clinic.

You may not qualify if:

• Have any one of the following conditions:
• Chronically infected "diabetic foot ulcers" or infections of chronic non-healing wounds of peripheral sites in a patient with advanced peripheral vascular disease;
• A wound infection involving foreign body or prosthetic material that will not be removed within 48 hours of initiation of treatment;
• Infected abdominal wounds unable to be surgically closed;
• Necrotizing fasciitis, rapidly necrotizing infections, or gangrenous processes;
• Infected burn involving \>20% of the total body surface area;
• Infected bite from human or animal origin.
• Erysipelas or a primary infection suspected or documented to be due to streptococci or infection with a Gram-negative pathogen without evidence of a concomitant staphylococcal infection
• Evidence of either a Gram-negative or Gram-positive pathogen not susceptible to treatment with protocol-specified antibiotics and AFN-12520000; or
• An existing abscess that cannot be drained within 48 hours of initiation of treatment;
• Unable to tolerate an oral formulation of antibiotic, have an underlying gastrointestinal disease (would be poorly absorbed or tolerated), have a medical condition or post-operative condition leading to significant gastrointestinal malabsorption, and/or are unable to tolerate a normal diet;
• Have a known or suspected non-skin source of infection such as endocarditis, osteomyelitis, retroperitoneal abscess, septic arthritis, meningitis, or pneumonia;
• Exhibit signs of severe sepsis:
• Plans to have surgery utilizing general anesthetic during the study period (except surgery to remove a prosthetic device complicating the infection site or surgery to drain the abscess/wound within 48 hours);
• Pregnant or breastfeeding women;

Sponsors & Collaborators

• Affinium Pharmaceuticals, Ltd: lead

Study Sites (14)

SITE 018

Buena Park, California, 90620, United States

Location

SITE 005

Chula Vista, California, 91911, United States

Location

SITE 001

La Mesa, California, 91942, United States

Location

SITE 016

Oceanside, California, 92056, United States

Location

SITE 017

Augusta, Georgia, 30909, United States

Location

SITE 002

Columbus, Georgia, 31904, United States

Location

SITE 004

Savannah, Georgia, 31406, United States

Location

SITE 006

Las Vegas, Nevada, 89109, United States

Location

SITE 003

Somers Point, New Jersey, 08244, United States

Location

SITE 007

Cincinnati, Ohio, 45267, United States

Location

SITE 011

Toledo, Ohio, 43608, United States

Location

SITE 008

Nashville, Tennessee, 37232, United States

Location

SITE 014

Edmonton, Alberta, T6G 2B7, Canada

Location

SITE 015

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

• Hafkin B, Kaplan N, Murphy B. Efficacy and Safety of AFN-1252, the First Staphylococcus-Specific Antibacterial Agent, in the Treatment of Acute Bacterial Skin and Skin Structure Infections, Including Those in Patients with Significant Comorbidities. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1695-701. doi: 10.1128/AAC.01741-15.

  PMID: 26711777 DERIVED

MeSH Terms

Conditions

Wound Infection; Cellulitis

Interventions

API 1252

Condition Hierarchy (Ancestors)

Infections; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Barry Hafkin, MD

  Affinium Pharmaceuticals, Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 27, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 7, 2012

Record last verified: 2012-08

Locations

CA (2); US (12)