NCT01519492

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Affinium Pharmaceuticals, Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	AFN-12520000	Two tablets taken in both the morning and evening on an empty stomach for a total daily dose 400 mg

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-01-27
• Last updated: 2012-08-07

Locations

14 sites across 2 countries: United States, Canada