A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections Due to Staphylococci
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.
Skin and Subcutaneous Tissue Bacterial Infections
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2, Open-Label, Multi-Center Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococci|
- Safety [ Time Frame: From time of consent to long term follow-up (max of 42 days) ] [ Designated as safety issue: Yes ]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.
- Pharmacokinetics [ Time Frame: Day 3, Day 5 and at EOT ] [ Designated as safety issue: No ]To assess the population pharmacokinetics (PK) of AFN 12520000 in patients with staphylococcal ABSSSI. PK measures will include Area Under the Curve (AUC), Maximum concentration (Cmax) and Half-life.
|Study Start Date:||February 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
100 mg tablet
Two tablets taken in both the morning and evening on an empty stomach for a total daily dose 400 mg
This open-label Phase 2 study is designed as a proof-of-concept study to evaluate the efficacy of a total daily dose of 400 mg of AFN-12520000 using a number of newly defined early endpoints, conventional endpoints, and composite endpoints to determine clinical response. Safety and tolerability will also be evaluated by conventional endpoints.
The study will enroll up to 100 patients with a clinically documented diagnosis of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) due to staphylococci. Patients meeting eligibility criteria will be identified and evaluated in a hospital or specialized clinic. After consent is obtained, the first dose of study medication will be administered. Daily clinical assessments will be conducted at the hospital and/or outpatient clinic during the first 5 days of treatment. Adverse events (AEs) and response to therapy will also be assessed.
The study will consist of a screening period, which includes the baseline visit; a treatment period, and an end-of-treatment (EOT) visit; and a follow-up period, which includes a short-term (Test-of-Cure [TOC]) follow-up (STFU/TOC) visit and a long-term follow-up (LTFU) visit.
Treatment regimens as short as 5 days (10 doses) and as long as 14 days (28 doses) will be permitted depending on individual response to treatment. The anticipated time commitment for patient participation in the study will be approximately 20 to 42 days from screening/baseline to the LTFU visit. The total duration of the study will be < 12 months.
|United States, California|
|Buena Park, California, United States, 90620|
|Chula Vista, California, United States, 91911|
|La Mesa, California, United States, 91942|
|Oceanside, California, United States, 92056|
|United States, Georgia|
|Augusta, Georgia, United States, 30909|
|Columbus, Georgia, United States, 31904|
|Savannah, Georgia, United States, 31406|
|United States, Nevada|
|Las Vegas, Nevada, United States, 89109|
|United States, New Jersey|
|Somers Point, New Jersey, United States, 08244|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45267|
|Toledo, Ohio, United States, 43608|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Edmonton, Alberta, Canada, T6G 2B7|
|Kingston, Ontario, Canada, K7L 2V7|
|Study Director:||Barry Hafkin, MD||Affinium Pharmaceuticals, Ltd|